MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience kits labeled as: 1) VENOUS ACCESS TRAY, Pack Number CVI4830A; 2) DIALYSIS INSERTION BUNDLE-ADD CATHETER, Pack Number CVI4835; 3) DIALYSIS TAKE

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 distribution. Lot/code info: CVI4830A, Lot Number 2022072850; CVI4835, Lot Number 2022061350; CVI4835, Lot Number 2022072850; CVI4835, Lot Number 2023111490; CVI4835, Lot Number 2023112790; DT18185, Lot Number 23EBS508 ; DT18185, Lot Number 23FBU960 ; DT18185, Lot Number 23HBQ339 ; DT22005, Lot Number 21JBI227 ; DYNDC3274, Lot Number 2022111490; DYNDC3274, Lot Number 2023101190; DYNDC3274, Lot Number 2023112790; DYNDH1531, Lot Number 2022111490; DYNJTS4301, Lot Number 2022061350; DYNJTS4301, Lot Number 2022061350; DYNJTS4306, Lot Number 2022061350; DYNJTS8100, Lot Number 2022061350; PT215, Lot Number 2022061350; SUT19360, Lot Number 2022111490

Source

Official record: FDA (Device enforcement) ↗

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