FDA Updates

Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY TRAY, Pack Number DYNJ32049A ; 3) BREAST BIOPSY PACK, Pack Number DYNJ44987G ; 4) BREAST BIOPSY PACK, Pack Number DYNJ66288

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

Medline Convenience kits labeled as: 1) FETOSCOPY CDS-LF, Pack Number CDS840215O ; 2) BONE RETRIEVAL PART A , Pack Number CDS981237F ; 3) BASIC BIOPSY TRAY , Pack Number DYNDA1217A ; 4) ONCOLOGY PORT ACCESS TRAY , Pack Number DYNDC2239; 5) US BREAST BIOPSY TRAY, Pack Number DYNDH1187A; 6) BONE MARROW TRAY - TUBE HLDR, Pack Number DYNDH1286A; 7) BONE MARROW TRAY - TUBE HLDR, Pack Number DYNDH1286AH; 8) PACK,BREAST BIOPSY, Pack Number DYNDL1498; 9) BONE MARROW PACK, Pack Number DYNJ0628436I ; 10) SH STEREOTACTIC BIOPSY PK-LF, Pack Number DYNJ0660035K; 11) SH STEREOTACTIC BIOPSY PK-LF, Pack Number DYNJ0660035KH; 12) OPP MINOR PACK-LF , Pack Number DYNJ0706869I ; 13) OPP MINOR PACK-LF , Pack Number DYNJ0706869IH; 14) BIOPSY DRAPE PACK , Pack Number DYNJ20953F ; 15) STEREOTACTIC TRAY , Pack Number DYNJ28856D ; 16) BIOPSY TRAY , Pack Number DYNJ31585C ; 17) BONE MARROW KIT PK, Pack Number DYNJ37526; 18) CT BIOPSY PACK-LF , Pack Number DYNJ38414B ; 19) CUSTOM BONE CEMENT TRAY-LF, Pack Number DYNJ42702D ; 20) LIVER TRANSPLANT PACK , Pack Number DYNJ43493A ; 21) BIOPSY TRAY , Pack Number DYNJ49368; 22) BONE MARROW HARVEST PACK, Pack Number DYNJ50740A ; 23) HINKAMP ACCESSORY PACK, Pack Number DYNJ66550; 24) HINKAMP ACCESSORY PACK, Pack Number DYNJ66550A ; 25) NDN CUSTOM BONE RECOVERY, Pack Number DYNJ903942D; 26) MODULE BREAST BIOPSY, Pack Number DYNJ904158B; 27) PACK,FETOSCOPY, Pack Number DYNJ906905B; 28) MINOR/BREAST BIOPSY-LF, Pack Number DYNJS3035; 29) BREAST BIOPSY-LF, Pack Number DYNJT1911D ; 30) BIOPSY TRAY , Pack Number SPEC0150 ; 31) BIOPSY TRAY W/O LIDOCAINE , Pack Number SPEC0196B; 32) STEREOTACTIC BIOPSY TRAY, Pack Number SPEC0279

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

Medline Convenience kits labeled as: 1) URETEROSCOPY CDS SC-LF, Pack Number CDS983922F ; 2) URETEROSCOPY TRAY-RF, Pack Number DYNJ27442U ; 3) URETHROPLASTY PACK, Pack Number DYNJ39700B ; 4) RRP PACK, Pack Number DYNJ44109B ; 5) PROSTATECTOMY PACK-LF , Pack Number DYNJ66109A ; 6) PERINEAL PACK , Pack Number DYNJ69895; 7) LIVER 2018, Pack Number DYNJ905655A; 8) UROLOGY PACK, Pack Number DYNJT2255M

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

Medline Convenience kits labeled as: 1) COMPREHENSIVE PROCEDURE PACK, Pack Number 7791 ; 2) LAVH CDS, Pack Number CDS760049AC; 3) LAPAROSCOPY CDS , Pack Number CDS760051AB; 4) LAPAROSCOPY CDS , Pack Number CDS760051AC; 5) LAPAROSCOPY CDS , Pack Number CDS760051AD; 6) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057G ; 7) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057I ; 8) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057J ; 9) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057K ; 10) CYSTO PROCEDURE , Pack Number CDS760062P ; 11) CYSTO PROCEDURE , Pack Number CDS760062Q ; 12) LAPAROSCOPY CDS , Pack Number CDS830216F ; 13) FETAL SURGERY CDS-LF, Pack Number CDS840214Q ; 14) MINOR LAPAROTOMY CDS, Pack Number CDS860016P ; 15) MINOR LAPAROTOMY CDS, Pack Number CDS860016Q ; 16) MINOR LAPAROTOMY CDS, Pack Number CDS860016R ; 17) MINOR LAPAROTOMY CDS, Pack Number CDS860016S ; 18) THOROCOTOMY , Pack Number CDS860040I ; 19) LAPAROTOMY CDS #31-RF , Pack Number CDS860062Q ; 20) LAPAROTOMY CDS #31-RF , Pack Number CDS860062R ; 21) LAPAROTOMY CDS #31-RF , Pack Number CDS860062S ; 22) GYN LAP , Pack Number CDS860087K ; 23) GYN LAP , Pack Number CDS860087M ; 24) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107P ; 25) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107Q ; 26) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107R ; 27) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107S ; 28) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108K ; 29) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108L ; 30) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108M ; 31) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108N ; 32) LAP GASTRIC BYPASS CDS, Pack Number CDS860146J ; 33) LAP GASTRIC BYPASS CDS, Pack Number CDS860146K ; 34) LAP GASTRIC BYPASS CDS, Pack Number CDS860146L ; 35) LAP GASTRIC BYPASS CDS, Pack Number CDS860146M ; 36) ABDOMINAL ANEURYSM PROCEDURE, Pack Number CDS860181D ; 37) LAPAROSCOPY CDS , Pack Number CDS860194F ; 38) LAPAROSCOPY CDS , Pack Number CDS860194G ; 39) LAPAROSCOPY CDS , Pack Number CDS860194I ; 40) LAPAROSCOPY CDS , Pack Number CDS860229G ; 41) LAPAROSCOPY CDS-LF, Pack Number CDS860235G ; 42) LAPAROSCOPY CDS-LF, Pack Number CDS860235I ; 43) LAPAROSCOPY CDS-LF, Pack Number CDS860235J ; 44) BARI GASTRECTOMY CDS, Pack Number CDS860237AA; 45) BARI GASTRECTOMY CDS, Pack Number CDS860237AB; 46) BARI GASTRECTOMY CDS, Pack Number CDS860237AC; 47) BARI GASTRECTOMY CDS, Pack Number CDS860237X ; 48) BARI GASTRECTOMY CDS, Pack Number CDS860237Y ; 49) CYSTO , Pack Number CDS902753F ; 50) LAPAROSCOPIC CDS, Pack Number CDS920043T ; 51) BASIC LAPAROSCOPY CDS , Pack Number CDS920080P ; 52) BASIC LAPAROSCOPY CDS , Pack Number CDS920080Q ; 53) BASIC LAPAROSCOPY CDS , Pack Number CDS920080R ; 54) BASIC LAPAROSCOPY CDS , Pack Number CDS920080S ; 55) BASIC LAPAROSCOPY CDS , Pack Number CDS920080T ; 56) LAPAROSCOPIC, Pack Number CDS920082X ; 57) LAPAROSCOPIC, Pack Number CDS920082Y ; 58) LAPAROSCOPY CDS-LF, Pack Number CDS920104F ; 59) LAPAROSCOPY CDS-LF, Pack Number CDS920104G ; 60) LAPAROSCOPY CDS-LF, Pack Number CDS920104I ; 61) LAPAROSCOPY CDS-LF, Pack Number CDS920126AC; 62) GENERAL LAPAROSCOPY , Pack Number CDS930027T ; 63) GENERAL LAPAROSCOPY , Pack Number CDS930027U ; 64) GENERAL LAPAROSCOPY , Pack Number CDS930027V ; 65) LAP CHOLE CDS-LF, Pack Number CDS930030T ; 66) LAP CHOLE CDS-LF, Pack Number CDS930030U ; 67) LAP CHOLE , Pack Number CDS930089AA; 68) LAP CHOLE CDS , Pack Number CDS930111AA; 69) LAP CHOLE CDS , Pack Number CDS930111AB; 70) LAP CHOLE CDS-LF, Pack Number CDS930117J ; 71) MINOR BASIC-LF, Pack Number CDS930120G ; 72) MINOR BASIC-LF, Pack Number CDS930120I ; 73) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125R ; 74) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125S ; 75) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125T ; 76) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125U ; 77) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125V ; 78)

Medline Convenience kits labeled as: 1) VENOUS ACCESS TRAY, Pack Number CVI4830A; 2) DIALYSIS INSERTION BUNDLE-ADD CATHETER, Pack Number CVI4835; 3) DIALYSIS TAKE OFF KIT , Pack Number DT18185; 4) DIALYSIS TRAY , Pack Number DT22005; 5) PRE POST DIALYSIS, Pack Number DYNDC3274; 6) MYELOGRAM TRAY, Pack Number DYNDH1531; 7) ADULT LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4301; 8) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4306; 9) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS8100; 10) LUMBAR PUNCTURE TRAY, Pack Number PT215; 11) FINE LACERATION KIT, Pack Number SUT19360

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

Medline Convenience kits labeled as: PUH ESOPHAGECTOMY CDS, Pack Number CDS984309I

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

Medline Convenience kits labeled as: 1) GYN ENDOSCOPY KIT , Pack Number CDS981309O ; 2) GB GENERAL ENDO , Pack Number CDS984155F ; 3) ENDOSCOPY KIT , Pack Number DYKE1112 ; 4) ENDOSCOPY KIT , Pack Number DYKE1133A; 5) ENDOSCOPY PACK, Pack Number DYKE1264 ; 6) ENDOSCOPY KIT , Pack Number DYKE1389 ; 7) ENDO KIT, Pack Number DYKE1856 ; 8) WCH ENDO KIT, Pack Number DYKE1864B; 9) ENDO PACK , Pack Number DYNDA3058; 10) ENDOSCOPY PACK-LF , Pack Number DYNJ00339J ; 11) TR-ENT ENDO PACK-LF , Pack Number DYNJ0396027I ; 12) ENDOSCOPIC CHOLE PACK-LF, Pack Number DYNJ0426277J ; 13) GENERAL ENDOSCOPIC PACK-LF, Pack Number DYNJ22661L ; 14) GENERAL ENDOSCOPIC PACK-LF, Pack Number DYNJ22661O ; 15) ENDOSCOPY-LF, Pack Number DYNJ22890L ; 16) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673G ; 17) ENDOSCOPY PACK, Pack Number DYNJ50594C ; 18) ABD ENDOSCOPIC PACK , Pack Number DYNJ54221B ; 19) ABD ENDOSCOPIC PACK , Pack Number DYNJ54221C ; 20) ENDOSCOPIC PACK , Pack Number DYNJ54221J ; 21) CUSTOM ENDOSCOPY PACK-LF, Pack Number DYNJ55478B ; 22) CUSTOM ENDOSCOPY PACK-LF, Pack Number DYNJ55478D ; 23) ENDO PACK , Pack Number DYNJ56043B ; 24) ENDO PACK , Pack Number DYNJ56043C ; 25) ENDO PACK, Pack Number DYNJ56043F; 26) ENDO PACK , Pack Number DYNJ56043F ; 27) ENDOSCOPIC SKULL BASE , Pack Number DYNJ58648B ; 28) ENDOSCOPIC SKULL BASE , Pack Number DYNJ58648C ; 29) ENDOSCOPIC SKULL BASE , Pack Number DYNJ58648D ; 30) ENDOSCOPIC SKULL BASE , Pack Number DYNJ58648J ; 31) ENDO / AUG PACK , Pack Number DYNJ59250A ; 32) ENDO / AUG PACK , Pack Number DYNJ59250B ; 33) PACK ENDO AAA HYBRIDCHRG, Pack Number DYNJ60126B ; 34) DIPASCO GENERAL ENDOCRINE PACK, Pack Number DYNJ60686A ; 35) ENDOSCOPIC PACK , Pack Number DYNJ63797; 36) ENDOSCOPY PACK, Pack Number DYNJ65524; 37) GENERAL ENDOSCOPIC PK , Pack Number DYNJ66034A ; 38) ENT ENDO SINUS WILMINGTON PACK, Pack Number DYNJ66447; 39) ENDOVENOUS PACK , Pack Number DYNJ66596; 40) GENERAL ENDOSCOPIC PACK , Pack Number DYNJ67382B ; 41) PEDI ENDO LAP PACK, Pack Number DYNJ68141; 42) GEN ENDOSCOPY , Pack Number DYNJ81490; 43) PACK ENDOSCOPIC CHOLECYSTE, Pack Number DYNJ81539; 44) ENDO UROLOGY, Pack Number DYNJ83704A ; 45) ENDOSCOPY , Pack Number DYNJ900509N; 46) ENDOSCOPY , Pack Number DYNJ900509O; 47) ENDO OMH, Pack Number DYNJ900525C; 48) MODULE ENDO LAP , Pack Number DYNJ903026F; 49) MODULE ENDO LAP , Pack Number DYNJ903026G; 50) GENERAL ENDOSCOPY , Pack Number DYNJ903421D; 51) CYSTO , Pack Number DYNJ903521A; 52) GENERAL ENDOSCOPY , Pack Number DYNJ903826F; 53) ENDO, Pack Number DYNJ904836A; 54) ENDO, Pack Number DYNJ904836B; 55) ENDO, Pack Number DYNJ904836C; 56) ENDO, Pack Number DYNJ904836D; 57) DIPASCO GENERAL ENDOCRINE , Pack Number DYNJ906574 ; 58) ENDOSCOPIC SKULL BASE , Pack Number DYNJ908362B; 59) ENDOSCOPY KIT , Pack Number P830355A ; 60) ENDOSCOPY KIT , Pack Number P830355AH

Medline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI4720A ; 2) CVC INSERTION PACK, Pack Number CVI4720AH; 3) CATHETER INSERTION KIT CLABSI , Pack Number CVI4880; 4) CHEST INSERTION PACK-LF , Pack Number DYNJ17634D ; 5) URETEROSCOPY, Pack Number DYNJ45882A ; 6) TONSIL PACK CATH, Pack Number DYNJ65199A ; 7) CATH PLACEMENT RIB FRACTURE , Pack Number DYNJ66475B ; 8) UROLOGY ROBOTIC PACK, Pack Number DYNJ80211C ; 9) UROLOGY ROBOTIC PACK, Pack Number DYNJ80211CH; 10) UROLOGY PK, Pack Number DYNJ80252C ; 11) PORT INSERTION PACK , Pack Number DYNJ81597

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

Medline Convenience kits labeled as: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516BH; 3) DIALYSIS PACK , Pack Number DYNJ36932A ; 4) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 5) DIALYSIS ACCESS PACK, Pack Number DYNJ910121 ; 6) NO CATH DIALYSIS INSERTN TRAY , Pack Number PICCNC0028

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

Medline Convenience kits labeled as: 1) GB GENERAL ENDO , Pack Number CDS984155G ; 2) BAPTIST FLOYD ENDO GI KIT , Pack Number DYKE1455B; 3) ENDO KIT, Pack Number DYKE1487C; 4) BRONCH ENDO W/O BEDSIDE KIT , Pack Number DYKE1634 ; 5) ENDO KIT, Pack Number DYKE1696 ; 6) PULMONARY ENDO KIT, Pack Number DYKE1713 ; 7) ENDO KIT, Pack Number DYKE1739 ; 8) ENDOSCOPY PACK-LF , Pack Number DYNJ00339K ; 9) GENERAL ENDOSCOPIC PACK-LF, Pack Number DYNJ0190667K ; 10) CH UMBIL CATH W/INSTR PACK-LF, Pack Number DYNJ0622040Q; 11) ENDOSCOPY-LF, Pack Number DYNJ22890M ; 12) ENDOSCOPIC PACK , Pack Number DYNJ30434I ; 13) ENDOSCOPIC SINUS PACK , Pack Number DYNJ40644A ; 14) ENDOSCOPY PACK, Pack Number DYNJ40645B; 15) ENDO SURGICAL PACK WRO-LF , Pack Number DYNJ41870B ; 16) ENT PK 1008847, Pack Number DYNJ42319C ; 17) ENDOVENOUS BASIC PACK , Pack Number DYNJ42456D ; 18) UROLOGY ENDOSCOPE PACK 319738 , Pack Number DYNJ44638C ; 19) ENDOSCOPY PACK-LF , Pack Number DYNJ53271C ; 20) ENDOSCOPY , Pack Number DYNJ62133; 21) ENDOSCOPY PACK, Pack Number DYNJ62193; 22) ENDOVENOUS CORE PACK, Pack Number DYNJ62557; 23) ENDOSCOPY PACK, Pack Number DYNJ62914; 24) ENDOSCOPIC PACK , Pack Number DYNJ63797A ; 25) ENDOVENOUS ABLATION PACK, Pack Number DYNJ64059; 26) GENERAL ENDOSCOPY PACK, Pack Number DYNJ65371; 27) GYN ENDOSCOPY PACK, Pack Number DYNJ65372; 28) CV NEONATAL PACK, Pack Number DYNJ67356; 29) PEDI ENDO LAP PACK, Pack Number DYNJ68141A ; 30) ENSEMBLE CATHETER DIALYSE-LF, Pack Number DYNJ81973; 31) ENT , Pack Number DYNJ900282I; 32) MUH ENDOCRINE , Pack Number DYNJ901706J; 33) SEPTO/ENDO, Pack Number DYNJ902831D; 34) MODULE ENDO LAP , Pack Number DYNJ903026I; 35) CVOR ENDOSTENT, Pack Number DYNJ906465 ; 36) ENDOSCOPIC SKULL BASE , Pack Number DYNJ906630 ; 37) ENDO CHOLE TRAY , Pack Number LZ7759N; 38) CATHETERIZATION TRAY, Pack Number UVT1175; 39) UMBILICAL VESSEL INSERTION TRA, Pack Number UVT730; 40) TVS4000 ENDOVENOUS PACK, Pack Number TVS4000K

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

Medline Convenience kits labeled as: 1) CYSTO PACK, Pack Number DYNJ42742D; 2) CYSTO PACK, Pack Number DYNJ42799

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

Medline Convenience kits labeled as: PARACERVICAL PUDENDAL BLOCK TR, Pack Number DYNJRA1023

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

Medline Convenience kits labeled as: 1) PSP - VAMC LONG BEACH, Pack Number 146255; 2) INSERTION TRAY, Pack Number CVI5080; 3) INCISION & DRAINAGE TRAY, Pack Number DYNDA1063; 4) DRAINAGE ACCESS PACK 319701 , Pack Number DYNJ44599I ; 5) PROCEDURE DRAINAGE KIT, Pack Number DYNJ66416; 6) DRAINAGE TRAY , Pack Number DYNJ68767; 7) INCISION AND DRAINAGE TRAY, Pack Number P737057

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

Medline Convenience kits labeled as: 1) CHEST EXPLORATION CDS , Pack Number CDS920066K ; 2) CHEST EXPLORATION CDS , Pack Number CDS920066L ; 3) PLASTIC SMR CDS-LF, Pack Number CDS980088K ; 4) PLASTICS, Pack Number CDS980200AA; 5) PLASTICS, Pack Number CDS980200Y ; 6) BREAST/MINOR, Pack Number CDS980228W ; 7) PLASTIC CDS , Pack Number CDS980232U ; 8) PLASTIC CDS , Pack Number CDS980232V ; 9) PLASTIC CDS , Pack Number CDS980232W ; 10) PLASTIC CDS , Pack Number CDS980232X ; 11) LTP CDS-LF, Pack Number CDS980375L ; 12) PLASTIC CDS , Pack Number CDS980457R ; 13) PLASTIC CDS , Pack Number CDS980457S ; 14) PLASTIC CDS , Pack Number CDS980457T ; 15) BREAST AUG, Pack Number CDS980567R ; 16) BREAST AUG, Pack Number CDS980567S ; 17) LARGE PROCEDURE-LF, Pack Number CDS981257J ; 18) LARGE PROCEDURE-LF, Pack Number CDS981257K ; 19) BREAST CDS, Pack Number CDS981691N ; 20) MAJOR PLASTICS CDS, Pack Number CDS981958I ; 21) MAJOR PLASTIC CDS-LF, Pack Number CDS981978J ; 22) MINOR PLASTIC , Pack Number CDS982018K ; 23) MAJOR BREAST, Pack Number CDS982038S ; 24) VASAL RECONSTRUCTION, Pack Number CDS982042O ; 25) MINOR BREAST, Pack Number CDS982053M ; 26) MINOR BREAST, Pack Number CDS982053N ; 27) MINOR BREAST, Pack Number CDS982053O ; 28) MINOR BREAST, Pack Number CDS982053P ; 29) BREAST AUGMENTATION , Pack Number CDS982254K ; 30) BREAST AUGMENTATION , Pack Number CDS982254L ; 31) BREAST AUGMENTATION , Pack Number CDS982254M ; 32) BREAST REDUCTION CDS, Pack Number CDS982255G ; 33) BREAST REDUCTION CDS, Pack Number CDS982255I ; 34) BREAST REDUCTION, Pack Number CDS982255J ; 35) TYMPANOPLASTY , Pack Number CDS982720M ; 36) MAJOR BREAST CDS SJF-LF , Pack Number CDS982730M ; 37) REDUCTION CDS , Pack Number CDS982776J ; 38) REDUCTION CDS , Pack Number CDS982776K ; 39) REDUCTION CDS , Pack Number CDS982776L ; 40) HMT MAJOR BREAST/PLASTICS CDS , Pack Number CDS982860R ; 41) MAG PLASTIC CDS , Pack Number CDS982909I ; 42) MAG PLASTIC CDS , Pack Number CDS982909J ; 43) MAG PLASTIC CDS , Pack Number CDS982909K ; 44) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910K ; 45) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910L ; 46) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910M ; 47) MAG FREE FLAP CDS-LF, Pack Number CDS982911K ; 48) GENERAL BREAST, Pack Number CDS983058G ; 49) GENERAL BREAST, Pack Number CDS983058I ; 50) BASIC PLASTIC CDS-LF, Pack Number CDS983141C ; 51) BASIC PLASTIC CDS-LF, Pack Number CDS983141D ; 52) BREAST CDS, Pack Number CDS983148A ; 53) BREAST CDS, Pack Number CDS983148B ; 54) ZALE STEREOTACTIC CDS , Pack Number CDS983173I ; 55) CUH ABDOMINOPLASTY CDS, Pack Number CDS983176I ; 56) MAJOR CDS , Pack Number CDS983292D ; 57) PECTUS REPAIR , Pack Number CDS983353R ; 58) PECTUS REPAIR , Pack Number CDS983353S ; 59) PECTUS REPAIR , Pack Number CDS983353T ; 60) PECTUS REPAIR , Pack Number CDS983353U ; 61) PECTUS REPAIR , Pack Number CDS983353V ; 62) PECTUS REPAIR , Pack Number CDS983353X ; 63) MAMMOPLASTY-LF, Pack Number CDS983478J ; 64) MAMMOPLASTY-LF, Pack Number CDS983478K ; 65) MAMMOPLASTY-LF, Pack Number CDS983478L ; 66) PLASTICS FREE FLAP, Pack Number CDS983493L; 67) PLASTICS FREE FLAP, Pack Number CDS983493M; 68) PLASTIC TORSO-LF, Pack Number CDS983496I ; 69) PLASTIC TORSO-LF, Pack Number CDS983496J ; 70) PLASTIC TORSO-LF, Pack Number CDS983496K ; 71) PLASTIC TORSO-LF, Pack Number CDS983496L ; 72) PLASTIC HEAD AND NECK-LF, Pack Number CDS983498I ; 73) PLASTIC HEAD AND NECK-LF, Pack Number CDS983498J ; 74) ACH PLASTICS BREAST-LF, Pack Number CDS983639C ; 75) ACH PLASTICS BREAST-LF, Pack Number CDS983639D ; 76) ACH PLASTICS BREAST-LF, Pack Number CDS983639G ; 77) ACH PLASTICS BREAST-LF, Pack Number CDS983639I ; 78) ACH PLASTICS BREAST-LF, Pack Number CDS983639J ; 79) ACH PLASTICS BREAST-LF, Pack Number CDS983639K ; 80) NE BREAST AUGMENTATION CDS, Pack Number CDS983660C ; 81) NE BREAST RECON CDS , Pack Number CDS983660D ; 82) NE BREAST RECON

Medline Convenience kits labeled as: MUNCY PACK, Pack Number DYNJ03097D

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

Medline Convenience kits labeled as: 1) GER ARTH BASIN PK RFID-LF , Pack Number DYNJ0100999K ; 2) PEDIATRIC MAJOR BASIN PACK-LF , Pack Number DYNJ0154061C ; 3) EYE BASIN PACK-LF , Pack Number DYNJ0259872M ; 4) EYE BASIN PACK-LF , Pack Number DYNJ0259872MH; 5) BASIN DBL PACK-LF , Pack Number DYNJ0287720N ; 6) PRMC BASIN SET UP PACK-LF , Pack Number DYNJ0321828Q ; 7) PRMC BASIN SET UP PACK-LF , Pack Number DYNJ0321828R ; 8) STANDARD BASIN PACK-LF, Pack Number DYNJ0420605J ; 9) MINOR BASIN PACK-LF , Pack Number DYNJ0515988L ; 10) MINOR BASIN PACK-LF , Pack Number DYNJ0515988M ; 11) MAJOR BASIN PACK-LF , Pack Number DYNJ0515994Q ; 12) MAJOR BASIN SET-LF, Pack Number DYNJ0551335Q ; 13) MINOR BASIN PACK-LF , Pack Number DYNJ0551725M ; 14) MINOR BASIN PACK, Pack Number DYNJ0557071D ; 15) UROLOGY BASIN PACK-LF , Pack Number DYNJ0561216G ; 16) LAKELAND SINGLE BASIN PACK-LF , Pack Number DYNJ0619907I ; 17) LAKELAND SINGLE BASIN PACK-LF , Pack Number DYNJ0619907K ; 18) LKLND SNGL BASIN PK RFID-LF , Pack Number DYNJ0619907L ; 19) OPEN HEART C--BASIN PACK-LF, Pack Number DYNJ0867331G; 20) OPEN HEART C--BASIN PACK-LF, Pack Number DYNJ0867331I; 21) TOTAL KNEE BASIN B PACK-LF, Pack Number DYNJ0867555L ; 22) VAG DELIVERY BASIN-LF , Pack Number DYNJ16162I ; 23) MAJOR BASIN PACK, Pack Number DYNJ16629F ; 24) GENERAL BASIN PACK, Pack Number DYNJ16731J ; 25) ST. ANNE'S MINOR BASIN PACK , Pack Number DYNJ24622K ; 26) ST. ANNE'S MAJOR BASIN SET UP , Pack Number DYNJ24628M ; 27) B.A.P BASIN PACK, Pack Number DYNJ28855C ; 28) MAJOR PK W/BASIN MARYVIEW-LF, Pack Number DYNJ30506L ; 29) GYN LAPAROSCOPIC, Pack Number DYNJ31939D ; 30) MAJOR BASIN KIT , Pack Number DYNJ33438G ; 31) BASIN SET , Pack Number DYNJ33967D ; 32) MINOR BASIN PACK-LF , Pack Number DYNJ34575D ; 33) MINOR GEN BASIN PK 9128188-LF , Pack Number DYNJ35972L ; 34) BASIN PACK-LF , Pack Number DYNJ36419D ; 35) MINOR SINGLE BASIN PACK , Pack Number DYNJ37698K ; 36) MINOR SINGLE BASIN PACK , Pack Number DYNJ37698L ; 37) CVG BASIN PACK SC , Pack Number DYNJ38052G ; 38) NEURO BASIN PACK-LF , Pack Number DYNJ39461J ; 39) HEART BASIN TRAY, Pack Number DYNJ44396I ; 40) BASIN PACK, Pack Number DYNJ44706F ; 41) ARTHROSCOPY BASIN SET-LF, Pack Number DYNJ47944D ; 42) ARTHROSCOPY BASIN SET-LF, Pack Number DYNJ47944F ; 43) ORTHOPEDIC CUSTOM BASIN SET , Pack Number DYNJ47991J ; 44) ORTHOPEDIC CUSTOM BASIN SET , Pack Number DYNJ47991N ; 45) RMC BASIN PACK, Pack Number DYNJ48643K ; 46) RMC BASIN PACK, Pack Number DYNJ48643L ; 47) OPEN HEART BASIN PACK-6214, Pack Number DYNJ49530B ; 48) ROBOTIC BASIN PACK, Pack Number DYNJ49536B ; 49) MINOR BASIN PACK, Pack Number DYNJ50463D ; 50) MAJOR BASIN PACK, Pack Number DYNJ50464D ; 51) CSC-N TOWEL SET UP PACK , Pack Number DYNJ50876A ; 52) BASIN SET , Pack Number DYNJ50906F ; 53) PK-SET UP-LF, Pack Number DYNJ51808B ; 54) DOUBLE BASIN OR SET , Pack Number DYNJ51940C ; 55) TR-MINOR KIT-LF , Pack Number DYNJ54801D ; 56) TR-MINOR KIT-LF , Pack Number DYNJ54801F ; 57) TR-MINOR KIT-LF, Pack Number DYNJ54801F ; 58) MAJOR PACK, Pack Number DYNJ55895C ; 59) ORTHO PACK, Pack Number DYNJ55896C ; 60) LITHOTOMY PACK, Pack Number DYNJ55900C ; 61) LAMINECTOMY-DISCECTOMY PACK , Pack Number DYNJ57263B ; 62) BASIN PACK, Pack Number DYNJ57465D ; 63) MAJOR BASIN PACK, Pack Number DYNJ57928C ; 64) PK-MAD,SPINE, Pack Number DYNJ58060I ; 65) SINGLE BASIN PACK-LF, Pack Number DYNJ58389D ; 66) SINGLE BASIN PACK-LF, Pack Number DYNJ58389F ; 67) MINOR SINGLE BASIN-LF , Pack Number DYNJ59649A ; 68) MAJOR BASIN PACK, Pack Number DYNJ59816A ; 69) FLAP PACK , Pack Number DYNJ60224C ; 70) FLAP PACK, Pack Number DYNJ60224D; 71) SINGLE BASIN PACK ST VINCENT, Pack Number DYNJ60529A ; 72) SINGLE BASIN PACK ST VINCENT, Pack Number DYNJ60529B ; 73) SINGLE BASIN PACK ST VINCENT, Pack Number DYNJ60529C ; 74) SINGLE BASIN PACK ST VINCENT, Pack Number DYNJ60529D ; 75) AV FISTULA, Pack Number DYNJ60614C ; 76) BASIN PACK, Pack Number

Medline Convenience kits labeled as: 1) MYELOGRAM PACK, Pack Number 00-399025L ; 2) BIOPSY PROCEDURE PACK , Pack Number 00-399227G ; 3) BIOPSY PROCEDURE PACK, Pack Number 00-399607N; 4) THORACENTESIS TRAY, Pack Number 00-400616J ; 5) SPECIAL PROCEDURE PACKX-RAY , Pack Number 00-400830S ; 6) PROCEDURE PACK-LF , Pack Number 00-401585M ; 7) PTCA PACK , Pack Number 00-401800F ; 8) ANGIO PROCEDURE PACK, Pack Number 00-401824Y ; 9) PICC LINE TRAY, Pack Number 00-401993N ; 10) ARTERIOGRAM TRAY, Pack Number 00-402001S ; 11) CARDIAC CATH PACK , Pack Number 00-500502L ; 12) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377N; 13) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377O; 14) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377P; 15) KIT IR CUSTOM-ST CLOUD, Pack Number 131672; 16) KIT ANGIO CSTM, Pack Number 135169; 17) KIT NEURO 2-UIC, Pack Number 138557; 18) STOP THE BURDEN KIT IN PACK , Pack Number 139594 ; 19) KIT ANGIO CSTM-ST FRANCIS, Pack Number 142356; 20) TISSUE PROCUREMENT KIT1506US1 , Pack Number 1506US1; 21) BASIC TRIAL ACCESSORIES , Pack Number 190-0033-002 ; 22) PROC AC KIT LIDOCAINE , Pack Number 20060920 ; 23) PROCEDURAL ACC KIT, Pack Number 20060921 ; 24) DA VINCI ACCESSORIES KIT: GYN , Pack Number 387000 ; 25) DA VINCI ACCESSORIES KIT: UROL, Pack Number 387100 ; 26) DA VINCI ACCESSORIES KIT: GS, Pack Number 387200 ; 27) BASIC PROCEDURE PACK, Pack Number 7790 ; 28) COMP PROC PACK W/CHLORAPREP , Pack Number 7792 ; 29) PHLEBECTOMY PROCEDURE PACK, Pack Number 7793 ; 30) PROCEDURE PACK, RF, Pack Number 7795 ; 31) PROCEDURE PACK, RF, BASIC , Pack Number 7798 ; 32) SKIN RECOVERY PACK M1S0706-LF , Pack Number 922095 ; 33) CVHP DRAWER-SYR & TUBING VER.A, Pack Number ACC010309A ; 34) NEWBORN RESUSCITATION KIT , Pack Number ACC010381C ; 35) NEONATAL DRAWER 6 , Pack Number ACC010653; 36) ANGEL PERCUTANEOUS ACCESS KIT , Pack Number AK9035A; 37) RADIAL TRAY , Pack Number AM140A ; 38) RADIAL TRAY , Pack Number AM140B ; 39) SET UP TRAY , Pack Number AM235A ; 40) PACK SET UP , Pack Number AM235B ; 41) HEAD & NECK TRAY, Pack Number AM310A ; 42) 18GX6 FEMORAL ART MAX BARRIER KIT, Pack Number ART1230; 43) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 44) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 45) 20GX3" RADIAL ART LINE KIT, Pack Number ART970A; 46) BIOBURDEN TEST KIT - 110, Pack Number BIOB110; 47) BIOBURDEN TEST KIT - 686, Pack Number BIOB686; 48) BIOBURDEN TEST KIT - 710, Pack Number BIOB710; 49) BM ECTOPIC SINUS SURGERY, Pack Number BM100A ; 50) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056D ; 51) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056F ; 52) CYSTO PROCEDURE , Pack Number CDS760062O ; 53) NEURO CDS , Pack Number CDS780056M ; 54) SHUNT CDS-LF, Pack Number CDS780103J ; 55) TRAUMA/LIVER CDS-LF , Pack Number CDS780104J ; 56) TRAUMA/LIVER CDS-LF , Pack Number CDS780104K ; 57) UVALDE C-SECTION CDS, Pack Number CDS820116D ; 58) MAJOR VAGINAL PROCEDURE , Pack Number CDS830136R ; 59) VASCULAR EXTREMITY CDS-LF , Pack Number CDS840055O ; 60) AAA CDS , Pack Number CDS840076AB; 61) AAA CDS , Pack Number CDS840076X ; 62) AAA CDS , Pack Number CDS840076Y ; 63) OFF PUMP CABG CDS , Pack Number CDS840087AA; 64) OFF PUMP CABG CDS , Pack Number CDS840087AC; 65) OPEN HEART, Pack Number CDS840150Q ; 66) VALVE PACK, Pack Number CDS840187R ; 67) AV FISTULA PACK , Pack Number CDS840188L ; 68) MAJOR VASCULAR PACK , Pack Number CDS840195S ; 69) FETAL SURGERY CDS-LF, Pack Number CDS840214N ; 70) FETOSCOPY CDS-LF, Pack Number CDS840215N ; 71) MAJOR VASCULAR-LF , Pack Number CDS840232J ; 72) AVF-LF, Pack Number CDS840233D ; 73) AVF-LF, Pack Number CDS840233F ; 74) AVF-LF, Pack Number CDS840233G ; 75) GENERAL AAA #11-RF, Pack Number CDS840261AA; 76) THROMBECTOMY/AV FISTULA CDS-LF, Pack Number CDS840295F ; 77) PERIPHERAL INSERTION CDS-LF , Pack Number CDS840343K ; 78) THOROCOTOMY , Pack Number CDS840354N ; 79) THOROCOTOMY , Pack Number CDS840354O ; 80) THORO

Medline Convenience kits labeled as: 1) PRESSURE TUBING B.I., Pack Number 81239; 2) M1S1109 TRADITIONAL PROCESS-LF, Pack Number 946279 ; 3) 20GX6" FEMORAL ART LINE KIT, Pack Number ART1165; 4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210; 5) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 6) 18GX6" FEMORAL ART LINE KIT, Pack Number ART960A; 7) 20GX3" RADIAL ART LINE KIT, Pack Number ART970A; 8) BIOPSY TRAY, Pack Number BT1015; 9) BIOPSY TRAY, Pack Number BT1060; 10) STEREOTACTIC BREAST BIOPSY TRAY, Pack Number BT1095; 11) BIOPSY KIT, Pack Number BT450A ; 12) CHEST TUBE INSERTION TRAY , Pack Number CHT1020; 13) CHEST TUBE INSERTION KIT, Pack Number CHT1465; 14) CHEST TUBE INSERTION TRAY , Pack Number CHT2040; 15) CHEST TUBE INSERTION TRAY , Pack Number CHT2040H ; 16) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 17) CHEST TUBE INSERTION TRAY , Pack Number CHT701 ; 18) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 19) CIRCUMCISION TRAY, Pack Number CIT6260; 20) CIRCUMCISION TRAY, Pack Number CIT6325; 21) CIRCUMCISION TRAY , Pack Number CIT6575A ; 22) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 23) CHEST TUBE INSERTION TRAY , Pack Number CVI2105; 24) CHEST TUBE INSERTION TRAY , Pack Number CVI2105H ; 25) EXTREMITY PACK, Pack Number CVI4680; 26) CVC INSERTION PACK, Pack Number CVI4720; 27) VENOUS ACCESS TRAY, Pack Number CVI4830A; 28) VENOUS ACCESS TRAY, Pack Number CVI4830B; 29) MVHS CVC LUMEN TRAY, Pack Number CVI4920; 30) PEDS VASCULAR ACCESS KIT, Pack Number CVI4960A; 31) CATHETER ADD A CATH TRAY, Pack Number CVI4970; 32) CATHETER ON/OFF KIT, Pack Number DT5490B; 33) CHEST TUBE, UMBI LINE PK, Pack Number DYNDA1432A; 34) BIOPSY KIT, Pack Number DYNDA1466A; 35) CUP KIT, Pack Number DYNDA1506; 36) DERMATOLOGY KIT, Pack Number DYNDA1567D; 37) TDC REMOVAL, Pack Number DYNDA1633A; 38) PAN MP TRACHEOSTOMY, Pack Number DYNDA1635; 39) PERM CATH, Pack Number DYNDA1732A; 40) CATH REMOVAL, Pack Number DYNDA1733B; 41) CATH REMOVAL, Pack Number DYNDA1814; 42) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 43) ER MINOR SUTURE SET, Pack Number DYNDA1977A; 44) PORT TUNNEL CATH REMOVAL TRAY, Pack Number DYNDA2033A; 45) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063; 46) PULL D/C PACK, Pack Number DYNDA2080; 47) CONGENITAL ADD-ON KIT, Pack Number DYNDA2213A; 48) PAIN TRAY, Pack Number DYNDA2416; 49) STERILE 3CC SYR W/ 23GX1 NDL, Pack Number DYNDA2495; 50) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 51) ONCOLOGY-HEMOTOLOGY PREP TRAY-STERILE/LF, Pack Number DYNDA2523; 52) ONCOLOGY-HEMOTOLOGY PREP TRAY-STERILE/LF, Pack Number DYNDA2523A; 53) GENERAL UTILITY, Pack Number DYNDA2524; 54) SHUNT TRAY, Pack Number DYNDA2725; 55) CHILDRENS INFANT SP TRAY, Pack Number DYNDA2906; 56) PICU LINE TRAY, Pack Number DYNDC1960A; 57) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A; 58) PORT ACCESS KIT, Pack Number DYNDC2945; 59) PRE POST DIALYSIS, Pack Number DYNDC3274; 60) BMA BX TRAY, Pack Number DYNDH1050A; 61) BONE MARROW TRAY - NO NEEDLE, Pack Number DYNDH1059; 62) BIOPSY PACK SM, Pack Number DYNDH1093; 63) PQ BIOPSY PACK (BPSJH), Pack Number DYNDH1108; 64) ARTHROGRAM TRAY, Pack Number DYNDH1113; 65) BIOPSY/ARTHROGRAM TRAY, Pack Number DYNDH1115; 66) BIOPSY TRAY, Pack Number DYNDH1129; 67) ARTHROGRAM TRAY, Pack Number DYNDH1134; 68) BIOPSY PACK, Pack Number DYNDH1137A; 69) BIOPSY TRAY, Pack Number DYNDH1137C; 70) ARTHROGRAM PACK, Pack Number DYNDH1148; 71) ULTRASOUND TRAY, Pack Number DYNDH1204; 72) IR PICC TRAY, Pack Number DYNDH1223; 73) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227B; 74) BIOPSY TRAY-LF, Pack Number DYNDH1229; 75) ARTHROGRAM TRAY, Pack Number DYNDH1243; 76) BIOPSY PACK, Pack Number DYNDH1248; 77) BONE MARROW BIOPSY TRAY, Pack Number DYNDH1251; 78) BREAST BIOPSY TRAY, Pack Number DYNDH1257; 79) BIOPSY TRAY, Pack Number DYNDH1269; 80) BIOPSY TRAY, Pack Number DYNDH1273; 81) FLUORO PROCEDURE TRAY, Pack Number DYNDH1276; 82) BONE MARROW

Medline Convenience kits labeled as: 1) ECMO INSERTION BUNDLE W/O CANNULA, Pack Number CVI4915; 2) PORT ACCESS TRAY, Pack Number DYNDC1318D; 3) KNEE ARTHROSCOPY PACK-LF, Pack Number DYNJ0101308C ; 4) UNIVERSAL PLASTIC , Pack Number DYNJ04047C ; 5) JAM CATH LAB MINOR PACK , Pack Number DYNJ17507B ; 6) STARTER PACK CMH-LF , Pack Number DYNJ41737C ; 7) DELIVERY PACK ME-LF , Pack Number DYNJ45589B ; 8) STERILE STARTER SET PACK, Pack Number DYNJ47814; 9) IVF PACK, Pack Number DYNJ63783; 10) VI PACK , Pack Number DYNJ64811; 11) VI PACK , Pack Number DYNJ64871; 12) IR CENTRAL KIT, Pack Number DYNJ68285; 13) PICC KIT 4F SL PL MAX BARRIER, Pack Number PICC0011; 14) PICC KIT 4F SL PL MAX BARRIER, Pack Number PICC0012; 15) LACERATION TRAY, Pack Number SUT20955; 16) UMBILICAL VESSEL TRAY, Pack Number UVT1100A; 17) UMBILICAL INSERTION W/3.5 CATH, Pack Number UVT1225; 18) UMBILICAL INSERTION W/3.5 CATH, Pack Number UVT1225H ; 19) UMBILICAL TRAY W/3.5&5FR CATH , Pack Number UVT1250H

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

Medline Convenience kits labeled as: SCS-LF, DYNJ902314D

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