Open, ClassifiedPosted Sep 6, 2024·Initiated Apr 8, 2024
Medline Convenience kits, labeled as:
1) GAS SAM LINE .06ID 10FT MM FLT, Pack Number 35772 ;
2) ANES CIRC 90 EXP PEDS 2BV-LF, Pack Number 81842 ;
3) AIRWAY EXAM KIT, Pack Number DYKE1796 ;
4) INTUBATION KIT , Pack Number DYKSCRIPPSIN4;
5) INTUBATION KIT , Pack Number DYNDA1598C;
6) INTUBATION KIT , Pack Number DYNDA1598CH ;
7) ANESTHESIA KIT , Pack Number DYNDA2958;
8) ANESTHESIA PREP CUSTOM TRAY, Pack Number DYNDH1758;
9) ADULT LUMBAR PUNCTURE TRAY , Pack Number DYNDH1889;
10) PEDIATRIC CARDIAC PACK-LF, Pack Number DYNJ0537013Y;
11) PEDIATRIC MINOR PK, Pack Number DYNJ49035B;
12) WMC PEDIATRIC ADD ON PACK-LF, Pack Number DYNJ50644;
13) ANESTHESIA CVL KIT-LF, Pack Number DYNJ52283B;
14) ANESTHESIA CVL KIT-LF, Pack Number DYNJ52283C;
15) AIRWAY PACK , Pack Number DYNJ60239B;
16) ANESTHESIA PAIN PK LEAGUE, Pack Number DYNJ67925;
17) H-CABG INTRA OP ANESTHESIA , Pack Number DYNJ900603I ;
18) H-CABG INTRA OP ANESTHESIA , Pack Number DYNJ900603J ;
19) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503A ;
20) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503B ;
21) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503C ;
22) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503D ;
23) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503F ;
24) #######, Pack Number DYNJ905503F ;
25) MZ MDL AIRWAY, Pack Number DYNJ910129;
26) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA10379 ;
27) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA6572;
28) ANESTHESIA EVALUATION SAMPLE, Pack Number DYNJAASAMPLE;
29) ANESTHESIA EVALUATION SAMPLE, Pack Number DYNJAASAMPLE;
30) REGIONAL ANESTHESIA PREP TRAY , Pack Number DYNJRA0376A ;
31) ANESTHESIA KIT , Pack Number DYNJRA0424A ;
32) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0767;
33) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0767A ;
34) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0767B ;
35) ANESTHESIA SUPPORT TRAY , Pack Number DYNJRA0779A ;
36) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0887A ;
37) ANESTHESIA TRAY, Pack Number DYNJRA0909;
38) SPINAL ANESTHESIA TRAY/WHITE, Pack Number DYNJRA0955A ;
39) #####, Pack Number DYNJRA0955A ;
40) ANESTHESIA SUPPORT TRAY/B, Pack Number DYNJRA0968;
41) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA1119;
42) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA1119A ;
43) ANESTHESIA TRAY, Pack Number DYNJRA1355;
44) ANESTHESIA TRAY, Pack Number DYNJRA1355A ;
45) SPINAL ANESTHESIA TRAY, Pack Number DYNJRA1577A ;
46) ANESTHESIA SUPPORT TRAY/CHLORA, Pack Number DYNJRA1659;
47) ANESTHESIA SUPPORT TRAY/CHLORA, Pack Number DYNJRA1659A ;
48) SPINAL ANESTHESIA TRAY, Pack Number DYNJRA1757;
49) ANESTHESIA PREP KIT, Pack Number DYNJRA1899;
50) ANESTHESIA TRAY, Pack Number DYNJRA1934;
51) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA2087;
52) SPINAL ANESTHESIA TRAY, Pack Number DYNJRA2151;
53) PRE OP ANES KIT, Pack Number DYNJRA2228;
54) PRE OP ANES KIT, Pack Number DYNJRA2228H;
55) CUSTOM ANESTHESIA KIT-LF, Pack Number GSP478I;
56) REGIONAL TRAY, Pack Number PAIN0385B;
57) EPIDURAL ANESTHESIA KIT , Pack Number PAIN1982 ;
58) CIRC PACK-LF, Pack Number PHS41720I;
59) CIRC PACK-LF, Pack Number PHS41720J;
60) ANES CIRC 90 EXP, Pack Number VM96DLEX2L
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Circuit, Breathing (W Connector, Adaptor, Y Piece)Distribution: Worldwide distribution.Recall #Z-2983-2024
Open, ClassifiedPosted Sep 6, 2024·Initiated Apr 8, 2024
Medline Convenience kits, labeled as:
1) TRACHEOTOMY TRAY, Pack Number DYNDA1894;
2) TRACHEOSTOMY, Pack Number DYNJ45495G ;
3) TRACH PACK, Pack Number DYNJ46518G ;
4) EH EMERGENCY TRACH TRAY , Pack Number DYNJ50007A ;
5) EH EMERGENCY TRACH TRAY , Pack Number DYNJ50007B ;
6) ENT TRACHEOTOMY , Pack Number DYNJ55523C ;
7) DR NIELSON THORACOSCOPY , Pack Number DYNJ61471A ;
8) TRACH PACK, Pack Number DYNJ64583;
9) TRACHEOSTOMY, Pack Number DYNJ902123G;
10) TRACHEOSTOMY, Pack Number DYNJ902123I;
11) TRACHEOSTOMY, Pack Number DYNJ902123J;
12) (55) KIT STC TRACHEOSTOMY , Pack Number DYNJ909525 ;
13) (55) KIT STC TRACHEOSTOMY , Pack Number DYNJ909525H;
14) BEDSIDE TRACHEOTOMY , Pack Number DYNJ909743
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Tracheotomy Care KitDistribution: Worldwide distribution.Recall #Z-2984-2024
Open, ClassifiedPosted Sep 6, 2024·Initiated Apr 8, 2024
Medline Convenience kits, labeled as:
1) DYNJ39451D , Pack Number HOOD PACK ;
2) DYNJ59573A , Pack Number ICU RESPIRATORY BRONCH PACK ;
3) DYNJ80281A , Pack Number OSC BRONCH PACK
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Tracheobronchial Suction Catheter KitDistribution: Worldwide distribution.Recall #Z-2985-2024
Open, ClassifiedPosted Sep 6, 2024·Initiated Apr 8, 2024
Medline Convenience kits labeled as:
1) STERILE LIDOCAINE SYRINGE PACK, Pack Number DYNDM1076A ;
2) PEDIATRIC EP PACK , Pack Number DYNJ45158A ;
3) CARDIAC MINOR-LF, Pack Number DYNJ51939;
4) CARDIAC MINOR SURGICOUNT PACK , Pack Number DYNJ56573;
5) PEDIATRIC EP PACKMHS, Pack Number DYNJ58876A
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Custom Anesthesia TrayDistribution: Worldwide distribution.Recall #Z-2986-2024
Open, ClassifiedPosted Sep 6, 2024·Initiated Apr 8, 2024
Medline Convenience kits, labeled as:
1) SINGLE SHOT EPIDURAL PACK-LF, Pack Number DYNJ0708470K ;
2) EPIDURAL CSTM PACK-LF , Pack Number DYNJ0844004;
3) CUSTOM EPIDURAL PACK-LF , Pack Number DYNJ0934752F ;
4) EPIDURAL PACK-LF, Pack Number DYNJ0957053D ;
5) EPIDURAL PACK-LF, Pack Number DYNJ0957053DH;
6) SINGLE SHOT TRAY, Pack Number DYNJ32736;
7) CONTINUOUS EPIDURAL TRAY-LF , Pack Number DYNJ34352A ;
8) SINGLE SHOT EPIDURAL-LF , Pack Number DYNJ36046A ;
9) PHOENIXVILLE EPIDURAL TRAY, Pack Number DYNJ40991A ;
10) UNIVERSAL SCOPE PACK, Pack Number DYNJ45052A ;
11) SPINAL PACK , Pack Number DYNJ48916B ;
12) PUH SPINAL BLOCK TRAY , Pack Number DYNJ49205B ;
13) EPIDURAL PACK , Pack Number DYNJ50772A ;
14) TRANSFORAMINAL PACK , Pack Number DYNJC3420D ;
15) EPIDURAL PREP TRAY-LF , Pack Number DYNJRA0135B;
16) SUPPORT TRAY-LF, Pack Number DYNJRA0198;
17) SPINAL TRAY W/GERTIE MARX NDL , Pack Number DYNJRA0245 ;
18) EPIDURAL TRAY , Pack Number DYNJRA0260 ;
19) SPINAL EPIDURAL (TUOHY) PF, Pack Number DYNJRA0270B;
20) EPIDURAL TRAY-LF, Pack Number DYNJRA0275A;
21) SPINAL BLOCK TRAY- LF , Pack Number DYNJRA0413B;
22) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number DYNJRA0506A;
23) EPIDURAL TRAY , Pack Number DYNJRA0508 ;
24) SPINAL TRAY W/GERTIE MARX NDL , Pack Number DYNJRA0555 ;
25) COMBINED SPINAL/EPIDURAL PACK , Pack Number DYNJRA0635 ;
26) SPINAL BLOCK, 25G QUINCKE , Pack Number DYNJRA0766 ;
27) TRANSFORAMINAL 22X5PF , Pack Number DYNJRA0777F;
28) TRANSFORMINAL TRAY, Pack Number DYNJRA0822A;
29) SPINAL TRAY, Pack Number DYNJRA0836A;
30) SPINAL TRAY , Pack Number DYNJRA0978A;
31) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA0988 ;
32) TRAY, SPINAL, WHIT 24GX4, Pack Number DYNJRA1034 ;
33) TRANSFORAMINAL TRAY , Pack Number DYNJRA1730A;
34) SPINAL BLOCK 25G WHTCRE 5S BU , Pack Number DYNJRA9028 ;
35) SPINAL BLOCK 25G WHTCRE 5S BU , Pack Number DYNJRA9028H;
36) TRAY, SPINAL PENCIL POINT 25G , Pack Number DYNJRA9030 ;
37) SPINAL BLOCK TRAY, 22G QUINCKE, Pack Number DYNJRA9036 ;
38) SPINAL BLOCK TRAY, 22G QUINCKE, Pack Number DYNJRA9036H;
39) SPINAL BLOCK, 25G QUINCKE , Pack Number DYNJRA9037 ;
40) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0012 ;
41) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0024D;
42) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0055A;
43) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0058D;
44) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0078C;
45) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0082D;
46) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0111C;
47) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0133 ;
48) COMPLETE SINGLE SHOT TRAY , Pack Number PAIN0136A;
49) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0146C;
50) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0157G;
51) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0171C;
52) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0191I;
53) NORTON SINGLE SHOT EPIDURAL , Pack Number PAIN0215A;
54) EPIDURAL TRAY , Pack Number PAIN0225 ;
55) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0242B;
56) SINGLE SHOT EPIDURAL-LF , Pack Number PAIN0250A;
57) SINGLE SHOT EPIDURAL-LF , Pack Number PAIN0256B;
58) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0261A;
59) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0262A;
60) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0265C;
61) EPI TRAY, SINGLE , 20G-LF , Pack Number PAIN0274A;
62) EPI TRAY CONTI 17G TUOHY, Pack Number PAIN0275 ;
63) EPIDURAL TRAY-LF, Pack Number PAIN0279C;
64) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0280C;
65) SINGLE DOSE EPI-LF, Pack Number PAIN0300B;
66) SINGLE DOSE EPIDURAL TRAY-LF, Pack Number PAIN0317A;
67) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0334A;
68) EPIDURAL TRAY-LF, Pack Number PAIN0349B;
69) SINGLE DOSE EPIDURAL TRAY-LF, Pack Number PAIN0357B;
70) SHOT EPIDURAL TRAY-LF , Pack Number PAIN0362 ;
71) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0386B;
72) CONTINUOUS EPIDURAL TRAY, Pack Number PAIN0390 ;
73) SINGLE SHOT EPIDURAL T
Open, ClassifiedPosted Sep 6, 2024·Initiated Apr 8, 2024
Medline Convenience kits, labeled as:
1) NERVE BLOCK TRAY-LF, Pack Number DYNJRA0377B;
2) PERIPHERAL NERVE BLOCK, Pack Number PAIN0137
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Neurological TrayDistribution: Worldwide distribution.Recall #Z-2988-2024
Open, ClassifiedPosted Sep 6, 2024·Initiated Apr 8, 2024
Medline Convenience kits, labeled as:
SPINAL BLOCK 22G QUINCKE 5S BU, Pack Number DYNJRA9026
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Orthopedic TrayDistribution: Worldwide distribution.Recall #Z-2989-2024
Open, ClassifiedPosted Sep 6, 2024·Initiated Apr 8, 2024
Medline Convenience kits labeled as:
1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736 ;
2) KIT LEFT HEART-VA MED, Pack Number 132701;
3) KIT MANIFOLD CSTM-RENAISSANC, Pack Number 134085 ;
4) KIT LEFT HEART- LEXINGTON , Pack Number 142643 ;
5) KIT ANGIO CSTM-SETON, Pack Number 143267;
6) SYR- VA HOSPITAL, Pack Number 144684;
7) BYPASS ENCOMPASS CDS, Pack Number CDS985003A;
8) CSTM MANIFOLD KIT , Pack Number SAMPC0547;
9) CSTM MANIFOLD KIT - FRYE, Pack Number VASC1074 ;
10) CSTM MANIFOLD KIT , Pack Number VASC1130
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassDistribution: Worldwide distribution.Recall #Z-2990-2024
Open, ClassifiedPosted Sep 6, 2024·Initiated Apr 8, 2024
Medline Convenience kits labeled as:
CARDIAC PACING PACK, Pack Number DYNJ41223
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Electrode, Pacemaker, TemporaryDistribution: Worldwide distribution.Recall #Z-2991-2024
Open, ClassifiedPosted Sep 6, 2024·Initiated Apr 8, 2024
Medline convenience kits labeled as:
1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ;
2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG;
3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI;
4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ;
5) CATH LAB PACK , Pack Number 00-398725AM;
6) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399360K ;
7) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399734N ;
8) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983Q ;
9) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983R ;
10) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400065K ;
11) ANGIO PROCEDURE PACK, Pack Number 00-400069F ;
12) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AC;
13) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AD;
14) ANGIO PROCEDURE PACK, Pack Number 00-400290D ;
15) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400305Q ;
16) MOUNT SINAI HOSPITAL-ANGIO PK , Pack Number 00-400763F ;
17) ANGIOGRAPHY DRAPE PACK-LF , Pack Number 00-400863J ;
18) ANGIOGRAPHY DRAPE , Pack Number 00-400932O ;
19) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401030S ;
20) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401178D ;
21) ANGIO PROCEDURE PACK, Pack Number 00-401189I ;
22) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401226K ;
23) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318L ;
24) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318M ;
25) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327Y ;
26) CORONARY ANGIO PACK-LF, Pack Number 00-401594Q ;
27) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401620J ;
28) ANGIO PROCEDURE PACK, Pack Number 00-401824AA;
29) CATH LAB PACK-LF, Pack Number 00-HCT055P ;
30) CATH ACCESSORY PACK , Pack Number 0M-CP31433G;
31) CATH ACCESSORY PACK , Pack Number 0M-CP31433I;
32) ANGIO PACK, Pack Number 0M-CP31933C;
33) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357I;
34) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357J;
35) ANTERIOR CERVICAL CDS-LF, Pack Number CDS982292D ;
36) CABG 1, Pack Number CDS983663J ;
37) CATH CDS, Pack Number CDS984141I ;
38) ENDO AAA, Pack Number CDS984264I ;
39) ANGIOGRAPHY OR, Pack Number CDS984944C ;
40) ACCESS CATHETER , Pack Number CDS985507F ;
41) ARTHROSCOPY SHOULDER, Pack Number CDS985509F ;
42) SYMPHONY 5FR CATHETER KIT , Pack Number CTK-5K ;
43) SYMPHONY MAX 6FR CATHETER KIT , Pack Number CTK-6K ;
44) NEURO ANGIO PACK, Pack Number DYNDA1431A;
45) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0048560A ;
46) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429L ;
47) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429N ;
48) ANGIO TRAY-LF , Pack Number DYNJ0131200P ;
49) ANGIOGRAM , Pack Number DYNJ0149444J ;
50) ANGIOGRAM , Pack Number DYNJ0149444K ;
51) ANGIOGRAM , Pack Number DYNJ0149444M ;
52) EP LAB DEVICE PACK-LF , Pack Number DYNJ0160556D ;
53) PED CATH PROCEDURE CHILD PK-LF, Pack Number DYNJ0161241F ;
54) ANGIO PACK-LF , Pack Number DYNJ0165039M ;
55) ANGIO PACK-LF , Pack Number DYNJ0165039N ;
56) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AF;
57) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AG;
58) VASCULAR ANGIO PACK-LF, Pack Number DYNJ0201109AG;
59) ANGIOGRAPHY TRAY-LF , Pack Number DYNJ0220880V ;
60) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0241256L ;
61) ANGIO PACK-LF , Pack Number DYNJ0281048I ;
62) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0290716L ;
63) ANGIO PROCEDURE PACK-LF , Pack Number DYNJ0298504AG;
64) ANGIOGRAPHIC PACK-LF, Pack Number DYNJ0337491C ;
65) ARTERIOGRAM PACK-LF , Pack Number DYNJ0362293D ;
66) CATH LAB PACK-LF, Pack Number DYNJ0362352M ;
67) CATH PACK-LF, Pack Number DYNJ0367643Q ;
68) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0370415I ;
69) CATH LAB PACK-LF, Pack Number DYNJ0371696O ;
70) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0372025G ;
71) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098K ;
72) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098L ;
73) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098M ;
74) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0373221O ;
75) ANGIO PACK-LF , Pack Number DYNJ0373279M ;
76) INTERVENTIO
Open, ClassifiedPosted Sep 6, 2024·Initiated Apr 8, 2024
Medline Convenience kits labeled as:
1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O;
2) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036OH;
3) CATH ACCESSORY PACK, Pack Number 0M-CP31433J;
4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210;
5) PERF. ASSOC. CUT DOWN TRAY, Pack Number BM17BAD;
6) CATHETER ADD A CATH TRAY, Pack Number CVI4970;
7) BIOPSY TRAY, Pack Number DYNDH1129;
8) ARTHROGRAM TRAY, Pack Number DYNDH1134;
9) BRISTOL MYELOGRAM, Pack Number DYNDH1228;
10) LUMBAR TRAY, Pack Number DYNDH1540A;
11) RADIOLOGY BASIC PACK, Pack Number DYNDH1827;
12) BLOOD CULTURE KIT W/BOTTLES, Pack Number DYNDH1932;
13) BIOPSY PACK, Pack Number DYNDL1462B;
14) CATH LAB PACK-LF, Pack Number DYNJ0105963Q;
15) CARDIAC CATH HARPER PACK-LF, Pack Number DYNJ0161912G;
16) CATH LAB PACK-LF, Pack Number DYNJ0173400P;
17) CATH LAB PACK-LF, Pack Number DYNJ0194968AG;
18) PICC LINE PACK-LF, Pack Number DYNJ0275614F;
19) PEDI CATH PACK-LF, Pack Number DYNJ0429201L;
20) SPECIAL PROCEDURE ANGIO PACK, Pack Number DYNJ04386U;
21) RADIOLOGY PACK, Pack Number DYNJ04562S;
22) IR PACK, Pack Number DYNJ04674U;
23) IR PACK, Pack Number DYNJ04674UH;
24) LEFT HEART PACK-LF, Pack Number DYNJ0490280PH;
25) LT HEART/ANGIOGRAPHY PACK-LF, Pack Number DYNJ0537652AG;
26) SM CARDIAC CATH PACK-LF , Pack Number DYNJ0621195TH;
27) CATH LAB PACK-LF, Pack Number DYNJ0755738R;
28) CARDIAC CATH PACK-LF, Pack Number DYNJ0781476AAH ;
29) CARDIAC CATH PACK-LF, Pack Number DYNJ0781918NH;
30) CATH LAB PACK , Pack Number DYNJ07919GH;
31) PACEMAKER PACK-LF , Pack Number DYNJ0830939ACH ;
32) CARDIAC CATH PACK-LF, Pack Number DYNJ0843627G ;
33) PICC INSERTION PACK-LF, Pack Number DYNJ0880659D;
34) PEDS HEART CATH PACK-LF, Pack Number DYNJ0897998D;
35) RADIAL ARTERY CATH PACK-LF, Pack Number DYNJ0945414BH;
36) RADIAL ARTERY CATH PACK-LF, Pack Number DYNJ0945414CH;
37) CATH LAB PACK , Pack Number DYNJ10117JH;
38) CARDIAC CATH PACK, Pack Number DYNJ17081S;
39) DEPAUL ANGIO PROCEDURE PACK, Pack Number DYNJ19937I;
40) PV/PTA TRAY-RF, Pack Number DYNJ21944VH;
41) ANGIO TRAY, Pack Number DYNJ23438M;
42) ANGIO TRAY, Pack Number DYNJ23438N;
43) ANGIO TRAY, Pack Number DYNJ23438O;
44) ADULT CARDIAC CATH PACK, Pack Number DYNJ23455Q;
45) VIR PACK, Pack Number DYNJ23499MH;
46) HEART CATH-SMH, Pack Number DYNJ24483FH;
47) CATH LAB PACK , Pack Number DYNJ24802PH;
48) ANGIO DRAPE PACK, Pack Number DYNJ24806KH;
49) RADIOLOGY STD TRAY, Pack Number DYNJ25029RH;
50) CARDIAC CATH PACK, Pack Number DYNJ26305N;
51) DIAGNOSTIC ADULT-LF , Pack Number DYNJ27239DH;
52) HEART CATH LT PACK, Pack Number DYNJ31282I;
53) ANGIO PACK, Pack Number DYNJ31339I;
54) CARDIAC CATH PACK, Pack Number DYNJ31847I;
55) NEURO ANGIO TRAY-LF, Pack Number DYNJ34882M;
56) HEART CATH II PACK CHS-LF, Pack Number DYNJ35605M;
57) ISSAQUA CATH/IR PACK, Pack Number DYNJ36738G;
58) PEDS CARDIAC PACK, Pack Number DYNJ37418MH;
59) SPECIAL PROCEDURE PACK-LF, Pack Number DYNJ38050F;
60) SPECIAL PROCEDURE PACK-LF, Pack Number DYNJ38050FH;
61) SPECIAL PROCEDURE PACK, Pack Number DYNJ38314G;
62) MINOR SPECIAL PROCEDURE PACK, Pack Number DYNJ38326G;
63) CARDIAC CATH PACK, Pack Number DYNJ38866F;
64) PERM CATH TRAY, Pack Number DYNJ40423AH;
65) O R EMERGENCY PACK, Pack Number DYNJ40460CH;
66) CARDIAC CATH PACK, Pack Number DYNJ40511M;
67) CATH LAB PACK, Pack Number DYNJ40961A;
68) CARDIAC CATH TRAY, Pack Number DYNJ41050C;
69) CATH LAB PACK, Pack Number DYNJ43469D;
70) PK, RADIOLOGY, Pack Number DYNJ43816B;
71) CARDIAC CATH TRAY, Pack Number DYNJ45323F;
72) LEFT HEART, Pack Number DYNJ45984I;
73) CATH LAB PROCEDURE, Pack Number DYNJ46353F;
74) ANGIO PACK, Pack Number DYNJ46401B;
75) CARDIAC CATH TRAY, Pack Number DYNJ46402A;
76) CARDIAC CATH TRAY, Pack Number DYNJ46419C;
77) NEURO CATH PACK (NCLUA)227-LF, Pack Number DYNJ47646D;
78) NEURO CATH PACK (NCLUA)227-LF, Pack Number DYNJ47646F;
79) NEURO CATH PACK (NCLUA)227-LF, Pack Number DYNJ47646G;
80) NEURO
Open, ClassifiedPosted Sep 6, 2024·Initiated Apr 8, 2024
Medline Convenience kits labeled as:
KIT VASCULAR IVC FILTER PLACEM, Pack Number DYKMBNDL37AH
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Tracking, Soft Tissue, IntraoperativeDistribution: Worldwide distribution.Recall #Z-2994-2024
Open, ClassifiedPosted Sep 6, 2024·Initiated Apr 8, 2024
Medline convenience kits labeled as:
1) PERMANENT PACING, Pack Number 00-400361J ;
2) NORTON CHILDRENS CATH LAB-LF, Pack Number 00-401185Q ;
3) PACEMAKER TRAY, Pack Number 00-401521F ;
4) FEMORAL PACK, Pack Number 00-401525G ;
5) CARDIAC CATH PACK , Pack Number 00-401561K ;
6) CORONARY ANGIO PACK-LF, Pack Number 00-401594S ;
7) LEFT HEART TRAY , Pack Number 00-401880I ;
8) EP LAB PACEMAKER PACK , Pack Number 00-401893K ;
9) EP LAB PACEMAKER PACK , Pack Number 00-401893L ;
10) ADVANTEC-MLD, Pack Number 00-500510D ;
11) ADVANTEC-MLD, Pack Number 00-500510F ;
12) KIT ANGIO CSTM-WALKER, Pack Number 129969;
13) DIAGNOSTIC KIT, Pack Number 147943;
14) MSC - CRESCENT MEDICAL, Pack Number 149155;
15) VASC KIT AUGUSTA MED CEN PG , Pack Number 650123111;
16) OPEN HEART CDS, Pack Number CDS840015AK;
17) OPEN HEART CDS, Pack Number CDS840015AL;
18) OPEN HEART CDS, Pack Number CDS840015AM;
19) OPEN HEART CDS, Pack Number CDS840015AN;
20) OPEN HEART CDS, Pack Number CDS840015AO;
21) OPEN HEART CDS, Pack Number CDS840015AP;
22) OPEN HEART CDS, Pack Number CDS840015AQ;
23) OPEN HEART CDS, Pack Number CDS840015AQ;
24) OPEN HEART CDS, Pack Number CDS840016AD;
25) OPEN HEART CDS, Pack Number CDS840016AD;
26) OPEN HEART CDS, Pack Number CDS840023R ;
27) OPEN HEART CDS, Pack Number CDS840023S ;
28) OPEN HEART CDS, Pack Number CDS840023T ;
29) AAA CDS , Pack Number CDS840076AC;
30) OFF PUMP CABG CDS , Pack Number CDS840087AB;
31) OFF PUMP CABG CDS , Pack Number CDS840087AD;
32) OFF PUMP CABG CDS , Pack Number CDS840087AF;
33) OFF PUMP CABG CDS , Pack Number CDS840087AG;
34) OFF PUMP CABG CDS , Pack Number CDS840087AI;
35) OFF PUMP CABG CDS , Pack Number CDS840087AJ;
36) OFF PUMP CABG CDS , Pack Number CDS840087AK;
37) OFF PUMP CABG CDS , Pack Number CDS840087AL;
38) OPEN HEART CDS, Pack Number CDS840094L ;
39) OPEN HEART CDS, Pack Number CDS840094M ;
40) OPEN HEART CDS, Pack Number CDS840094N ;
41) OPEN HEART CDS, Pack Number CDS840094P ;
42) OPEN HEART CDS, Pack Number CDS840108J ;
43) OPEN HEART CDS, Pack Number CDS840108K ;
44) OPEN HEART CDS, Pack Number CDS840132N ;
45) OPEN HEART CDS, Pack Number CDS840132O ;
46) OPEN HEART CDS, Pack Number CDS840144O ;
47) OPEN HEART CDS, Pack Number CDS840144P ;
48) OPEN HEART CDS, Pack Number CDS840144Q ;
49) OPEN HEART CDS, Pack Number CDS840144Q ;
50) OPEN HEART CDS, Pack Number CDS840145S ;
51) OPEN HEART CDS, Pack Number CDS840145T ;
52) OPEN HEART CDS, Pack Number CDS840145U ;
53) OPEN HEART, Pack Number CDS840150R ;
54) OPEN HEART, Pack Number CDS840150S ;
55) OPEN HEART, Pack Number CDS840150T ;
56) OPEN HEART, Pack Number CDS840150U ;
57) OPEN HEART, Pack Number CDS840150V ;
58) PACEMAKER CDS , Pack Number CDS840162S ;
59) PACEMAKER CDS , Pack Number CDS840162T ;
60) PACEMAKER CDS , Pack Number CDS840162U ;
61) PACEMAKER CDS , Pack Number CDS840162V ;
62) OPEN HEART CDS, Pack Number CDS840171AA;
63) OPEN HEART CDS, Pack Number CDS840171AB;
64) OPEN HEART CDS, Pack Number CDS840171AC;
65) OPEN HEART CDS, Pack Number CDS840171AD;
66) HEART CDS , Pack Number CDS840179M ;
67) HEART CDS, Pack Number CDS840179M ;
68) MINOR VASCULAR PACK , Pack Number CDS840184M ;
69) MINOR VASCULAR PACK , Pack Number CDS840184N ;
70) MINOR VASCULAR PACK , Pack Number CDS840184O ;
71) MINOR VASCULAR PACK, Pack Number CDS840184P;
72) OPEN HEART PACK , Pack Number CDS840185S ;
73) OPEN HEART PACK , Pack Number CDS840185T ;
74) OPEN HEART PACK , Pack Number CDS840185U ;
75) OPEN HEART PACK , Pack Number CDS840185V ;
76) OPEN HEART PACK , Pack Number CDS840185W ;
77) VALVE PACK, Pack Number CDS840187S ;
78) VALVE PACK, Pack Number CDS840187T ;
79) OPEN HEART, Pack Number CDS840189R ;
80) MAJOR VASCULAR, Pack Number CDS840195T ;
81) MAJOR VASCULAR, Pack Number CDS840195U ;
82) CABG-LF , Pack Number CDS840231Q ;
83) CABG-LF , Pack Number CDS840231R ;
84) CABG-LF , Pack Number CDS840231S ;
85) CABG-LF , Pack Number CDS840231T ;
86) MAJOR VASCU
Open, ClassifiedPosted Sep 6, 2024·Initiated Apr 8, 2024
Medline Convenience kits labeled as:
1) DIALYSIS CATHETER INSERTION KIT, Pack Number CVI4815;
2) ANGIO PACK, Pack Number CVI5045;
3) CHILDRENS INFANT SP TRAY, Pack Number DYNDA2906;
4) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319;
5) BIOPSY TRAY, Pack Number DYNDH1693A;
6) PACK,ULTRASOUND, Pack Number DYNDL1461;
7) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4306;
8) ARTHROGRAM TRAY, Pack Number SPEC0143A;
9) PD CATH KIT, Pack Number UVT1205
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Catheter Introducer KitDistribution: Worldwide distribution.Recall #Z-2996-2024
Open, ClassifiedPosted Sep 6, 2024·Initiated Apr 8, 2024
Medline Convenience kits labeled as:
1) PUNCTURE TRAY , Pack Number 00-401649G ;
2) PICC LINE TRAY, Pack Number 00-401993O ;
3) ARTERIOGRAM TRAY, Pack Number 00-402001T ;
4) ARTERIOGRAM TRAY, Pack Number 00-402001U ;
5) HEALTH LINE MAX BARRIER KIT , Pack Number A134-MAX ;
6) ART-LINE SURGERY PACK-LF, Pack Number ARTNC175 ;
7) AV FISTULA PACK , Pack Number CDS840188M ;
8) VP SHUNT, Pack Number CDS840193V ;
9) THROMBECTOMY/AV FISTULA CDS-LF, Pack Number CDS840295G ;
10) IVC PLACEMENT CDS-LF, Pack Number CDS860033A ;
11) IVC PLACEMENT CDS-LF, Pack Number CDS860033AH;
12) CENTRAL LINE CDS, Pack Number CDS930092V ;
13) CENTRAL LINE CDS, Pack Number CDS930092W ;
14) CENTRAL LINE CDS, Pack Number CDS930092X ;
15) C LINE INSERTION CDS, Pack Number CDS980379I ;
16) C LINE INSERTION CDS, Pack Number CDS980379J ;
17) AV FISTULA - SMH, Pack Number CDS980916L ;
18) AV FISTULA CDS, Pack Number CDS981513G ;
19) VASCULAR ACCESS CDS , Pack Number CDS981552F ;
20) VP SHUNT CDS, Pack Number CDS981740G ;
21) VP SHUNT CDS, Pack Number CDS981740I ;
22) PORT A CATH , Pack Number CDS982047Q ;
23) SHY VP SHUNT CDS, Pack Number CDS982389J;
24) MINI VASCULAR CDS QVH-LF, Pack Number CDS982524F ;
25) A-V FISTULA , Pack Number CDS982637K ;
26) A-V FISTULA , Pack Number CDS982637L ;
27) VASCULAR TRAUMA , Pack Number CDS982641K ;
28) AV FISTULA CDS, Pack Number CDS982660G ;
29) AV FISTULA CDS, Pack Number CDS982660I ;
30) PORT/TRACH INSERTION CDS-3, Pack Number CDS983004D ;
31) AV FISTULA/ACCESS , Pack Number CDS983060I ;
32) AV FISTULA/ACCESS , Pack Number CDS983060J ;
33) AV SHUNT CDS, Pack Number CDS983098B ;
34) AV SHUNT CDS, Pack Number CDS983098C ;
35) VASCULAR ACCESS CDS , Pack Number CDS983105C ;
36) VP SHUNT, Pack Number CDS983366K ;
37) VP SHUNT, Pack Number CDS983366L ;
38) AV FISTULA, Pack Number CDS983638G ;
39) AV FISTULA, Pack Number CDS983638I ;
40) AV FISTULA, Pack Number CDS983638J ;
41) BARIATRIC CDS , Pack Number CDS983657J ;
42) BARIATRIC CDS , Pack Number CDS983657K ;
43) BARIATRIC CDS , Pack Number CDS983883C ;
44) GROTH AV FISTULA CDS, Pack Number CDS984191P ;
45) GROTH AV FISTULA CDS, Pack Number CDS984191Q ;
46) GROTH AV FISTULA CDS, Pack Number CDS984191S ;
47) GROTH LASER VEIN CDS, Pack Number CDS984193Q ;
48) GROTH LASER VEIN, Pack Number CDS984193R;
49) SHY AV FISTULA CDS, Pack Number CDS984512G ;
50) AV FISTULA, Pack Number CDS985510G ;
51) THORACOSTOMY TRAY , Pack Number CHT2010;
52) TRAUMA CHEST TUBE SET , Pack Number CHT2015;
53) BARD MYPICC$ KIT, Pack Number CK000234A;
54) BARD MYPICC$ KIT, Pack Number CK000236A;
55) BARD MYPICC$ KIT, Pack Number CK000324 ;
56) BARD MYPICC$ KIT, Pack Number CK000325 ;
57) BARD MYPICC$ KIT, Pack Number CK000645A;
58) BARD MYPICC$ KIT, Pack Number CK000646A;
59) BARD MYPICC$ KIT, Pack Number CK000647A;
60) BARD MYPICC$ KIT, Pack Number CK000713 ;
61) BARD MYPICC$ KIT, Pack Number CK000714 ;
62) CENTRAL LINE TRAY , Pack Number CVI4705;
63) CVC INSERTION PACK, Pack Number CVI4720;
64) ****, Pack Number CVI4720B ;
65) KIT LINE INSERTION, Pack Number CVI4730;
66) KIT LINE INSERTION, Pack Number CVI4730A ;
67) VENOUS ACCESS TRAY, Pack Number CVI4830B ;
68) PORT INSERTION PACK , Pack Number CVI4870;
69) MVHS CVC LUMEN TRAY , Pack Number CVI4920;
70) NO CATHETER BUNDLE, Pack Number CVI4925A ;
71) UAMS PORT INSERTION KIT , Pack Number CVI5040;
72) CVL INSERTION PACK, Pack Number CVI5065;
73) CVL INSERTION PACK, Pack Number CVI5065H ;
74) HEMODIALYSIS TRAY , Pack Number DT8800 ;
75) ERCP KIT, Pack Number DYKE1006A;
76) PULMONARY KIT , Pack Number DYKE1870 ;
77) PULMONARY KIT, Pack Number DYKE1870H;
78) KIT SURG ONC INSERT CENT.VENOU, Pack Number DYKMBNDL43A;
79) ULTRASOUND PACK , Pack Number DYNDA1249A ;
80) CT SCAN-TC, Pack Number DYNDA1380A ;
81) CT SCAN-TC, Pack Number DYNDA1380AH;
82) UMBILICAL ARTERIAL/VENOUS KIT, Pack Number DYNDA2077;
83) BAL KIT , Pack Number DYNDA2137B ;
84) STERILE PRE OP PACK , Pack Number
Open, ClassifiedPosted Sep 6, 2024·Initiated Apr 8, 2024
Medline Convenience kits labeled as:
1) BIOPSY PROCEDURE PACK, Pack Number 00-400162J;
2) BIOPSY PROCEDURE TRAY , Pack Number 00-400405C ;
3) BIOPSY DRAPE PACK , Pack Number 00-400762H ;
4) BIOPSY PROCEDURE PACK , Pack Number 00-400832N ;
5) BIOPSY PROCEDURE PACK , Pack Number 00-400832O ;
6) BIOPSY PROCEDURE PACK , Pack Number 00-400832P ;
7) BIOPSY PROCEDURE PACK , Pack Number 00-401261F ;
8) 6" FEMORAL ARTERIALLINE KIT, Pack Number ART245B;
9) BREAST BIOPSY KIT , Pack Number BT1085A;
10) BREAST BIOPSY PROCEDURE TRAY, Pack Number BX8375F;
11) BREAST/MINOR, Pack Number CDS980228X ;
12) BIOPSY CDS-LF , Pack Number CDS984667D ;
13) BIOPSY CDS-LF , Pack Number CDS984667F ;
14) BREAST-HERNIA-PORT CDS-LF , Pack Number CDS984853G ;
15) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A;
16) QSUM STEREO/US BIOPSY TRAY, Pack Number CT101;
17) PEDS VASCULAR ACCESS KIT, Pack Number CVI4960;
18) BIOPSY DEKALB PACK, Pack Number DM150A ;
19) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645;
20) COLONOSCOPY KIT , Pack Number DYKE1218 ;
21) BREAST BIOPSY KIT , Pack Number DYNDA1224B ;
22) TDC REMOVAL, Pack Number DYNDA1633A;
23) BREAST BIOPSY PACK, Pack Number DYNDA2378A ;
24) CUSTOM BIOPSY TRAY, Pack Number DYNDA2448;
25) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497;
26) BIOPSY/MYELOGRAM PACK, Pack Number DYNDA2655;
27) PICU LINE TRAY, Pack Number DYNDC1960A;
28) PORT ACCESS KIT, Pack Number DYNDC2945;
29) CT BIOPSY TRAY, Pack Number DYNDH1054;
30) PQ BIOPSY PACK (BPSJH), Pack Number DYNDH1108;
31) BIOPSY PACK , Pack Number DYNDH1110;
32) ARTHROGRAM TRAY, Pack Number DYNDH1113;
33) BIOPSY TRAY , Pack Number DYNDH1114;
34) BIOPSY TRAY, Pack Number DYNDH1129;
35) ARTHROGRAM TRAY, Pack Number DYNDH1134;
36) BIOPSY PACK , Pack Number DYNDH1137A ;
37) BREAST BIOPSY TRAY, Pack Number DYNDH1142C ;
38) BREAST BIOPSY TRAY, Pack Number DYNDH1152A ;
39) BIOPSY KIT, Pack Number DYNDH1156;
40) ULTRASOUND TRAY, Pack Number DYNDH1204;
41) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227A;
42) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227B;
43) CORE BIOPSY TRAY, Pack Number DYNDH1233;
44) BIOPSY PACK, Pack Number DYNDH1248;
45) BREAST BIOPSY TRAY, Pack Number DYNDH1257;
46) BREAST BIOPSY TRAY, Pack Number DYNDH1266;
47) GENERAL BIOPSY TRAY , Pack Number DYNDH1268;
48) BIOPSY TRAY, Pack Number DYNDH1269;
49) OHS CT BIOPSY TRAY -LF, Pack Number DYNDH1270;
50) DB CT BIOPSY TRAY -LF , Pack Number DYNDH1270;
51) BIOPSY TRAY , Pack Number DYNDH1273;
52) BIOPSY PACK TAA COMPLIANT , Pack Number DYNDH1294;
53) BREAST BIOPSY TRAY, Pack Number DYNDH1296B ;
54) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297;
55) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297;
56) ISHAK IR DRAINAGE TRAY, Pack Number DYNDH1300;
57) BREAST BIOPSY TRAY, Pack Number DYNDH1302;
58) BREAST BIOPSY TRAY, Pack Number DYNDH1302H ;
59) BIOPSY TRAY, Pack Number DYNDH1314;
60) BIOPSY TRAY , Pack Number DYNDH1314A ;
61) MAMMOGRAPHY BREAST BIOPSY, Pack Number DYNDH1318;
62) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319;
63) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324;
64) BIOPSY TRAY, Pack Number DYNDH1328;
65) CT BIOPSY TRAY, Pack Number DYNDH1355A ;
66) BONE MARROW BIOPSY ASPIRATION , Pack Number DYNDH1376A ;
67) BREAST BIOPSY PACK, Pack Number DYNDH1425;
68) THYROID BIOPSY PACK , Pack Number DYNDH1430A ;
69) BONE MARROW BIOPSY KIT, Pack Number DYNDH1434;
70) SOFT TISSUE BIOPSY, Pack Number DYNDH1477;
71) ULTRASOUND BREAST BIOPSY, Pack Number DYNDH1496A ;
72) ULTRASOUND BREAST BIOPSY, Pack Number DYNDH1496AH;
73) BREAST BIOPSY , Pack Number DYNDH1518A ;
74) BIOPSY, Pack Number DYNDH1543;
75) BIOPSY PACK , Pack Number DYNDH1556;
76) BIOPSY PACK , Pack Number DYNDH1556D ;
77) IR BIOPSY TRAY, Pack Number DYNDH1569;
78) BIOPSY KIT, Pack Number DYNDH1570;
79) STEREOTACTIC BIOPSY , Pack Number DYNDH1572;
80) ULTRASOUND BIOPSY , Pack Number DYNDH1573A ;
81) BREAST BIOPSY , Pack Number DYNDH1575;
82) CT BIOP
Open, ClassifiedPosted Sep 6, 2024·Initiated Apr 8, 2024
Medline Convenience kits labeled as:
1) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010J ;
2) ORAL SURGERY PACK , Pack Number DYNJ00354K ;
3) ORAL PACK-LF, Pack Number DYNJ0426048L ;
4) ORAL SURGERY PACK-LF, Pack Number DYNJ17477F ;
5) ORAL SURGERY PACK-LF, Pack Number DYNJ17477G ;
6) ORAL SURGERY PACK-LF, Pack Number DYNJ20491N ;
7) DENTAL PACK-LF, Pack Number DYNJ36724C ;
8) DENTAL PACK WRM-LF, Pack Number DYNJ41963C ;
9) DENTAL SURGICOUNT , Pack Number DYNJ45540D ;
10) DENTAL PACK , Pack Number DYNJ49021F ;
11) DENTAL PACK , Pack Number DYNJ49021G ;
12) EXTRACTION PACK , Pack Number DYNJ49329F ;
13) CSC-N ORAL SURGERY PACK , Pack Number DYNJ50873B ;
14) ORAL SURGERY PACK , Pack Number DYNJ52404D ;
15) ORAL SURGERY PACK , Pack Number DYNJ52404F ;
16) ORAL SURGERY PACK , Pack Number DYNJ52404G ;
17) ORAL SURGERY PK RFID, Pack Number DYNJ52404I ;
18) WCMC PEDS DENTAL PACK , Pack Number DYNJ56307A ;
19) MAJOR PERIO DENTAL KIT, Pack Number DYNJ58157A ;
20) MAJOR PERIO DENTAL KIT, Pack Number DYNJ58157B ;
21) SURGERY KIT , Pack Number DYNJ58158A ;
22) SURGERY KIT , Pack Number DYNJ58158B ;
23) ORL PACK, Pack Number DYNJ59073B ;
24) ORAL SURGERY, Pack Number DYNJ59941B ;
25) ORAL SURGERY, Pack Number DYNJ59941BH;
26) MINOR DENTAL PACK-LF, Pack Number DYNJ61727I ;
27) MINOR DENTAL PACK-LF, Pack Number DYNJ61727J ;
28) MINOR DENTAL PACK-LF, Pack Number DYNJ61727K ;
29) MINOR DENTAL PACK-LF, Pack Number DYNJ61727L ;
30) DENTAL PACK , Pack Number DYNJ62779D ;
31) DENTAL PACK , Pack Number DYNJ62779F ;
32) DENTAL PACK , Pack Number DYNJ62779G ;
33) ORAL SURGERY PACK , Pack Number DYNJ66450B ;
34) ORAL PACK NTX , Pack Number DYNJ68506C ;
35) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226A ;
36) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226B ;
37) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226C ;
38) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226D ;
39) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226DH;
40) DENTAL PACK , Pack Number DYNJ80375;
41) ORAL SURGERY PACK , Pack Number DYNJ80619;
42) ORAL SURGERY PACK , Pack Number DYNJ80619A ;
43) DEAN DENTAL PACK, Pack Number DYNJ80644;
44) DEAN DENTAL PACK, Pack Number DYNJ80644A ;
45) DENTAL MINOR PACK , Pack Number DYNJ83140;
46) DENTAL PACK , Pack Number DYNJ84533;
47) ORAL SURGERY PACK-LF, Pack Number DYNJ84849;
48) ORAL, Pack Number DYNJ902377G;
49) ORAL SURGERY PACK-LF, Pack Number DYNJ904595D;
50) NYGH-MAJOR DENTAL-LF, Pack Number DYNJ905540F;
51) NYGH-MINOR DENTAL-PLASTIC-LF, Pack Number DYNJ905551C;
52) NORTH DENTAL, Pack Number DYNJ906941B;
53) ORAL, Pack Number DYNJ908371 ;
54) ORAL, Pack Number DYNJ908371A;
55) ORAL, Pack Number DYNJ908371B;
56) ORAL, Pack Number DYNJ908371C;
57) DENTAL, Pack Number DYNJ909635 ;
58) DENTAL, Pack Number DYNJ909635A
Open, ClassifiedPosted Sep 6, 2024·Initiated Apr 8, 2024
Medline Convenience kits labeled as:
TONSIL & ADENOID PACK, Pack Number DYNJ43427C
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Tube, Tonsil SuctionDistribution: Worldwide distribution.Recall #Z-3000-2024
Open, ClassifiedPosted Sep 6, 2024·Initiated Apr 8, 2024
Medline Convenience kits labeled as:
1) ZALE STEREOTACTIC CDS , Pack Number CDS983173G ;
2) ZALE OTOLOGY CDS, Pack Number CDS983181D ;
3) BGMC GENERAL LAPAROSCOPY PK-LF, Pack Number DYNJ0664747A ;
4) NC3G MEDIASTINOSCOPY PACK-LF, Pack Number DYNJ0796243D ;
5) MEDIASTINOSCOPY PACK-LF , Pack Number DYNJ0796243F ;
6) RHINOPLASTY PACK, Pack Number DYNJ27333F ;
7) OSC OTOLOGY PACK-LF , Pack Number DYNJ37384C ;
8) OSC OTOLOGY PACK-LF , Pack Number DYNJ37384D ;
9) RHINO PACK, Pack Number DYNJ46504A ;
10) RHINO PACK, Pack Number DYNJ46504B ;
11) MEDIASTINOSCOPY TEGH-LF , Pack Number DYNJ46741B ;
12) PACEMAKER PACK, Pack Number DYNJ49787A ;
13) NASAL AND SINUS PACK, Pack Number DYNJ50425A ;
14) MSC SEPTO RHINO PACK-LF , Pack Number DYNJ51677A ;
15) MSC SEPTO RHINO PACK-LF , Pack Number DYNJ51677B ;
16) SEPTO RHINO PACK, Pack Number DYNJ53076C ;
17) PLASTIC ENT PACK - NTSC , Pack Number DYNJ54901A ;
18) RHINO/SEPTO/FESS PACK , Pack Number DYNJ55955B ;
19) RHINO/SEPTO/FESS PACK , Pack Number DYNJ55955C ;
20) MEDIASTINOSCOPY PACK, Pack Number DYNJ60872B ;
21) NOSE ESC, Pack Number DYNJ62371A ;
22) NASAL PACK, Pack Number DYNJ67789A ;
23) LOU MAJOR ENT , Pack Number DYNJ901851D;
24) LOU MINOR ENT , Pack Number DYNJ901852C;
25) RHYZOTOMY , Pack Number DYNJ902288G;
26) CHS NASAL AND SINUS PACK, Pack Number DYNJCH501
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Tray, Surgical, EntDistribution: Worldwide distribution.Recall #Z-3001-2024
Open, ClassifiedPosted Sep 6, 2024·Initiated Apr 8, 2024
Medline Convenience kits labeled as:
1) HEAD & NECK TRAY, Pack Number AM310B ;
2) HEAD & NECK CDS , Pack Number CDS780161K ;
3) HEAD & NECK CDS , Pack Number CDS780161L ;
4) HEAD & NECK PROCEDURE , Pack Number CDS780170R ;
5) HEAD & NECK PROCEDURE , Pack Number CDS780170S ;
6) CAROTID CDS-LF, Pack Number CDS840056N ;
7) CAROTID-LF, Pack Number CDS860039J ;
8) T & A PROCEDURE-LF, Pack Number CDS860047X ;
9) THORACOTOMY CDS , Pack Number CDS920065R ;
10) EAR CDS , Pack Number CDS980089L ;
11) EAR CDS , Pack Number CDS980089M ;
12) EAR CDS , Pack Number CDS980089N ;
13) EAR CDS , Pack Number CDS980089O ;
14) ENDOSCOPY , Pack Number CDS980201R ;
15) TYMPANOPLASTY , Pack Number CDS980203R ;
16) TYMPANOPLASTY , Pack Number CDS980203S ;
17) TYMPANO CDS , Pack Number CDS980374M ;
18) TYMPANO CDS , Pack Number CDS980374O ;
19) TYMPANO CDS , Pack Number CDS980374P ;
20) THORACOTOMY CDS , Pack Number CDS980446T ;
21) SINUS CDS , Pack Number CDS980579D ;
22) EENT-HEAD AND NECK, Pack Number CDS980809K ;
23) EENT-HEAD AND NECK, Pack Number CDS980809L ;
24) EENT-HEAD AND NECK, Pack Number CDS980809M ;
25) FESS PROCEDURE, Pack Number CDS981185B ;
26) CDS981571P, Pack Number CDS981571P ;
27) SINUS CDS-LF, Pack Number CDS981692J ;
28) EAR CDS , Pack Number CDS981985F ;
29) MAJOR EAR , Pack Number CDS982016Q ;
30) MAJOR EAR , Pack Number CDS982016R ;
31) MAJOR EAR , Pack Number CDS982016S ;
32) MAJOR EAR , Pack Number CDS982016T ;
33) SINUS , Pack Number CDS982020O ;
34) SINUS , Pack Number CDS982020P ;
35) SINUS , Pack Number CDS982020R ;
36) NASAL/SEPTAL, Pack Number CDS982049M;
37) NASAL/SEPTAL, Pack Number CDS982049O;
38) T&A CDS-LF, Pack Number CDS982091I ;
39) EAR-EENT CDS, Pack Number CDS982307F ;
40) EAR-EENT CDS, Pack Number CDS982307G ;
41) EAR-EENT CDS, Pack Number CDS982307J ;
42) BASIC ENT CDS-WRMC, Pack Number CDS982329F ;
43) BASIC ENT CDS-WRMC, Pack Number CDS982329G ;
44) BASIC ENT CDS-WRMC, Pack Number CDS982329I ;
45) BASIC ENT CDS-WRMC, Pack Number CDS982329K ;
46) BAPTIST NORTH T&A SINUS CDS , Pack Number CDS982394B ;
47) MINOR HEAD&NECK CDS MRH-LF, Pack Number CDS982598K ;
48) EAR CDS-LF, Pack Number CDS982612B ;
49) T AND A CDS MRH , Pack Number CDS982622L ;
50) CAROTID , Pack Number CDS982638J ;
51) NASAL CDS , Pack Number CDS982655C ;
52) NASAL CDS , Pack Number CDS982655D ;
53) NASAL CDS , Pack Number CDS982655F ;
54) NECK THYROID, Pack Number CDS982692M ;
55) NECK THYROID, Pack Number CDS982692N ;
56) NECK THYROID, Pack Number CDS982692O ;
57) TYMPANOPLASTY , Pack Number CDS982720N ;
58) TYMPANOPLASTY , Pack Number CDS982720P ;
59) TYMPANOPLASTY , Pack Number CDS982720Q ;
60) TYMPANOPLASTY , Pack Number CDS982720R ;
61) SWEDISH CHERRY HILL EAR CDS , Pack Number CDS982778I ;
62) SWEDISH CHERRY HILL EAR CDS , Pack Number CDS982778J ;
63) SINUS CDS-1 , Pack Number CDS982901F ;
64) MIDDLE EAR CDS, Pack Number CDS982938J ;
65) MIDDLE EAR CDS, Pack Number CDS982938K ;
66) MIDDLE EAR CDS, Pack Number CDS982938L ;
67) MIDDLE EAR CDS, Pack Number CDS982938O ;
68) SMR/RHINO CDS , Pack Number CDS982939L ;
69) SMR/RHINO CDS , Pack Number CDS982939M ;
70) SMR/RHINO CDS , Pack Number CDS982939N ;
71) SMR/RHINO CDS , Pack Number CDS982939Q ;
72) SMR/RHINO CDS , Pack Number CDS982939R ;
73) SMR/RHINO CDS , Pack Number CDS982939S ;
74) T&A CDS , Pack Number CDS982944J ;
75) T&A CDS , Pack Number CDS982944K ;
76) MINOR EAR , Pack Number CDS982989K ;
77) MINOR EAR , Pack Number CDS982989L ;
78) MINOR EAR , Pack Number CDS982989M ;
79) MINOR EAR , Pack Number CDS982989N ;
80) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010G ;
81) ENT CDS , Pack Number CDS983035J ;
82) ENT CDS , Pack Number CDS983035L ;
83) ENT CDS , Pack Number CDS983035M ;
84) CHP SINUS ENDOSCOPY CDS , Pack Number CDS983087G ;
85) CHP TYMPMASTOID CDS, Pack Number CDS983088J;
86) HEAD & NECK CDS , Pack Number CDS983126B ;
87) HEAD & NECK CDS , Pack Number CDS983126C ;
88) CAROTID CDS-