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FDA (Device enforcement)Recalled 2024-04-08class ii

MEDLINE INDUSTRIES, LP - Northfield: Medline procedural kits labeled as: 1) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417 ; 2) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417A; 3) DRAWER 9L

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide Lot/code info: ACC010417, Lot Numbers: 21JDC136; ACC010417, Lot Numbers: 21LDA261; ACC010417, Lot Numbers: 22BDA205; ACC010417, Lot Numbers: 22FDB645; ACC010417A , Lot Numbers: 23GDA903; ACC010417A , Lot Numbers: 23HDA001; ACC010417A , Lot Numbers: 23HDB495; ACC010417A , Lot Numbers: 23IDA233; ACC010417A , Lot Numbers: 23IDB522; ACC010417A , Lot Numbers: 23JDB187; ACC010427A , Lot Numbers: 23EDA979; ACC010427A , Lot Numbers: 23IDB947; ACC010605, Lot Numbers: 22LDB120; ACC010605, Lot Numbers: 23ADB200; ACC010605, Lot Numbers: 23ADB656; ACC010605, Lot Numbers: 23BDA934; ACC010641, Lot Numbers: 23GDC055; ACC010653, Lot Numbers: 23HDC266; ACC010690, Lot Numbers: 23IDA111; ACC010690, Lot Numbers: 23IDB053; ACC010690, Lot Numbers: 24CDB296; ACC010784, Lot Numbers: 24CDA251; CIT4845, Lot Numbers: 2022070190; CIT6535, Lot Numbers: 2023122680; CIT6720, Lot Numbers: 2022050290; CIT6720, Lot Numbers: 2023052690; CIT6720A, Lot Numbers: 2023111090; CIT6780, Lot Numbers: 2023052690; CIT6920, Lot Numbers: 2022030890; CIT6925, Lot Numbers: 2022051690; CIT6925, Lot Numbers: 2022101090; CIT6925, Lot Numbers: 2023062690; CIT7095, Lot Numbers: 2022071390; CMPJ03205D , Lot Numbers: 24BBI377; CMPJ09869B , Lot Numbers: 23HMH649; CMPJ09869B , Lot Numbers: 23KMB759; CMPJ09869B , Lot Numbers: 24AME944; CMPJ21114P , Lot Numbers: 24CBJ402; DYKE1764 , Lot Numbers: 22FBS049; DYKE1764 , Lot Numbers: 23ABO112; DYKE1764 , Lot Numbers: 23CBR915; DYKE1764 , Lot Numbers: 23IBF012; DYKM1360A, Lot Numbers: 23FBT211; DYKS1256B,

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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