Open, ClassifiedPosted Sep 11, 2024·Initiated Jul 26, 2024
Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers
SMN: 10995490
Reason: Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample
results above a concentration of 110 U/mL.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic CancerDistribution: Worldwide - US Nationwide distributionRecall #Z-3100-2024 Open, ClassifiedPosted Sep 11, 2024·Initiated Jul 26, 2024
Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers
SMN:10995489
Reason: Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample
results above a concentration of 110 U/mL.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic CancerDistribution: Worldwide - US Nationwide distributionRecall #Z-3101-2024 Open, ClassifiedPosted Sep 11, 2024·Initiated Jul 26, 2024
Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers
SMN: 11206239
Reason: Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample
results above a concentration of 110 U/mL.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic CancerDistribution: Worldwide - US Nationwide distributionRecall #Z-3102-2024 Open, ClassifiedPosted Sep 11, 2024·Initiated Jul 26, 2024
ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers
SMN: 10491379
SMN: 11206239
Reason: Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample
results above a concentration of 110 U/mL.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic CancerDistribution: Worldwide - US Nationwide distributionRecall #Z-3103-2024 Open, ClassifiedPosted Sep 11, 2024·Initiated Jul 26, 2024
ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers
SMN: 10491244
Reason: Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample
results above a concentration of 110 U/mL.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic CancerDistribution: Worldwide - US Nationwide distributionRecall #Z-3104-2024 Open, ClassifiedPosted Sep 11, 2024·Initiated Jun 27, 2024
Medline Semi-rigid suction liners labeled as follows:
a) SEMI RIGID SUCTION LINER, REF OR515;
b) SEMI RIGID SUCTION LINER WITH TUBING, REF OR526K;
c) SEMI RIGID SUCTION LINER WITH TUBING, REF OR527K;
d) SEMI RIGID SUCTION LINER WITH TUBING, REF OR529K
Reason: Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Root cause: Process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Bottle, Collection, VacuumDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama.Recall #Z-3105-2024
Open, ClassifiedPosted Sep 11, 2024·Initiated Jun 27, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows:
a) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA0311C;
b) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA0323C;
c) ANESTHESIA CIRCUIT ADULT, Pack Number DYNJAA0378A;
d) ADULT ANESTHESIA CIRC LAGUNA, Pack Number DYNJAA10579;
e) BREATHING CIRCUIT # 34827, Pack Number DYNJAAF6674I
Reason: Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Root cause: Process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Circuit, Breathing (W Connector, Adaptor, Y Piece)Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama.Recall #Z-3106-2024
Open, ClassifiedPosted Sep 11, 2024·Initiated Jun 27, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows:
a) OPEN HEART KIT,ALTA BATES HOSP, Pack Number DYK1002174I;
b) ENDO KIT, Pack Number DYKE1558B;
c) ENDO KIT, Pack Number DYKE1804A;
d) VASCULAR-LF, Pack Number DYNJ900714C;
e) MAJOR CARDIOVASC ADULT, Pack Number DYNJ905472B;
f) AV FISTULA, Pack Number DYNJ908096A
Reason: Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Root cause: Process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Cardiovascular Procedure KitDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama.Recall #Z-3107-2024
Open, ClassifiedPosted Sep 11, 2024·Initiated Jun 27, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows: DENTAL, Pack Number DYNJ909451A
Reason: Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Root cause: Process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: General Purpose Dental TrayDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama.Recall #Z-3108-2024
Open, ClassifiedPosted Sep 11, 2024·Initiated Jun 27, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows:
a) BAPTIST FLOYD BRONCHOSCOPY, Pack Number DYKE1456D;
b) ENT MINOR, Pack Number DYNJ908099B;
c) HEAD & NECK, Pack Number DYNJ908101B;
d) NASAL FESS, Pack Number DYNJ908105B;
e) NASAL-LF, Pack Number DYNJ908429;
f) MASTOPEXY-CANNOVA, Pack Number DYNJ909948
Reason: Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Root cause: Process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Ear, Nose, And Throat Surgical TrayDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama.Recall #Z-3109-2024
Open, ClassifiedPosted Sep 11, 2024·Initiated Jun 27, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows:
a) MINOR PROCEDURE, Pack Number CDS981509C;
b) GENERAL LAPAROSCOPY CDS, Pack Number CDS981512J;
c) OR MAJOR CDS, Pack Number CDS981515D;
d) MAJOR-LF, Pack Number DYNJ900709C;
e) MAJOR-LF, Pack Number DYNJ900709D;
f) GENERAL LAPAROSCOPY-LF, Pack Number DYNJ900723C;
g) GENERAL LAPAROSCOPY-LF, Pack Number DYNJ900723D;
h) CYSTO, Pack Number DYNJ908098A;
i) MINOR LAPAROTOMY, Pack Number DYNJ908428;
j) MERCY TIFFIN BASIC LAP-LF, Pack Number DYNJ909730
Reason: Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Root cause: Process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Laparoscopy KitDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama.Recall #Z-3110-2024
Open, ClassifiedPosted Sep 11, 2024·Initiated Jun 27, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows:
a) ENDO BRONCH PACK, Pack Number DYKE1355;
b) ENDO BASIC KIT, Pack Number DYKE1356;
c) ENDOSCOPY KIT, Pack Number DYKE1771C
Reason: Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Root cause: Process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Endoscope Introducer KitDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama.Recall #Z-3111-2024
Open, ClassifiedPosted Sep 11, 2024·Initiated Jun 27, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows:
a) ENDO KIT, Pack Number DYKE1350D;
b) ENDO KIT, Pack Number DYKE1514B
Reason: Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Root cause: Process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Foley Catheter Kit (Excludes Hiv Testing)Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama.Recall #Z-3112-2024
Open, ClassifiedPosted Sep 11, 2024·Initiated Jun 27, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows:
a) MINOR BREAST, Pack Number DYNJ908104B;
b) PLASTIC MAJOR, Pack Number DYNJ908106B;
c) ABDOMINOPLASTY W/LIPO SUCTION, Pack Number DYNJ909946;
d) PLASTIC, Pack Number DYNJ909951
Reason: Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Root cause: Process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Plastic Surgery And Accessories KitDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama.Recall #Z-3113-2024
Open, ClassifiedPosted Sep 11, 2024·Initiated Jun 27, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows:
a) ENDO KIT, Pack Number DYKE1092B;
b) VIDEO BRONCHOSCOPY TRAY, Pack Number DYKE1666;
c) SUCTION CANISTER KIT, Pack Number DYKM2196;
d) SUCTION CANISTER KIT, Pack Number DYKM2196H;
e) BRONCH LAB PACK-LF, Pack Number DYNJ24810B;
f) THORACIC, Pack Number DYNJ907991F;
g) RECTAL, Pack Number DYNJ908108A;
h) ROBOTIC, Pack Number DYNJ908109C;
i) CERVICAL, Pack Number DYNJ908748D;
j) LAMI, Pack Number DYNJ908750D;
k) MERCY TIFFIN BASIC-LF, Pack Number DYNJ909731;
l) MERCY TIFFIN LITHOTOMY, Pack Number DYNJ909735;
m) BASIC GENERAL SET UP, Pack Number DYNJ909945;
n) BASIC GENERAL SET UP, Pack Number DYNJ909945A;
o) AMB OCULOPLASTICS MUSC, Pack Number DYNJ910289;
p) AMB OCULOPLASTICS MUSC, Pack Number DYNJ910289H;
q) MTHZ TOTAL HIP, Pack Number DYNJC9311M;
r) BRONCH KIT, Pack Number P906877
Reason: Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Root cause: Process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: General Surgery TrayDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama.Recall #Z-3114-2024
Open, ClassifiedPosted Sep 11, 2024·Initiated Jun 27, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows: NICU ADMIT KIT, Pack Number DYKA1014G
Reason: Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Root cause: Process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Patient Personal Hygiene KitDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama.Recall #Z-3115-2024
Open, ClassifiedPosted Sep 11, 2024·Initiated Jun 27, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows: ANES TURNOVER KIT-LF, Pack Number DYNJAA10338J
Reason: Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Root cause: Process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Body Fluid Clean Up KitDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama.Recall #Z-3116-2024
Open, ClassifiedPosted Sep 11, 2024·Initiated Jun 27, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows: KIT NEURO SHUNT ST LOUIS CHILD, Pack Number DYNJ907829B
Reason: Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Root cause: Process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Neurological TrayDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama.Recall #Z-3117-2024
Open, ClassifiedPosted Sep 11, 2024·Initiated Jun 27, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows:
MTHZ GYN LAPAROSCOPY, Pack Number DYNJ909739
Reason: Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Root cause: Process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Gynecological Laparoscopic KitDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama.Recall #Z-3118-2024
Open, ClassifiedPosted Sep 11, 2024·Initiated Jun 27, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows: MERCY TIFFIN C-SECTION, Pack Number DYNJ909732
Reason: Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Root cause: Process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Cesarean Section TrayDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama.Recall #Z-3119-2024