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FDA (Device enforcement)Recalled 2025-02-11class ii

MEDLINE INDUSTRIES, LP - Northfield: Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; 2) ANGIO PACK, Pack Number DYNJ30501F; 3) ANGIO PACK-LF, Pack Number DYNJ0954970G; 4) ANG

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 - US Nationwide and the country of Canada. Quantity: 1939 units Lot/code info: 1) Pack Number DYNJ50624A: UDI/DI 10889942474639 (each) 40889942474630 (case), Lot Number 20BDB393A; 2) Pack Number DYNJ30501F: UDI/DI 10889942806683 (each) 40889942806684 (case), Lot Number 21HBP134A; 3) Pack Number DYNJ0954970G: UDI/DI 10193489505634 (each) 40193489505635 (case), Lot Number 21GMA850A; 4) Pack Number DYNJ33597J: UDI/DI 10889942802012 (each) 40889942802013 (case), Lot Number 21IMD296A; 5) Pack Number DYNJ38120B: UDI/DI 10884389722145 (each) 40884389722146 (case), Lot Number 21BBI114A; 6) Pack Number DYNJ42873: UDI/DI 10888277011298 (each) 40888277011299 (case), Lot Number 23EBE560A; 7) Pack Number DYNJ57498: UDI/DI 10889942745746 (each) 40889942745747 (case), Lot Number 21AMA569A; 8) Pack Number DYNJ52167A: UDI/DI 10193489541106 (each) 40193489541107 (case), Lot Number 21GMB606A; 9) Pack Number DYNJV0173I: UDI/DI 10889942965021 (each) 40889942965022 (case), Lot Number 23CLA070A; 10) Pack Number DYNJ58722A: UDI/DI 10193489329698 (each) 40193489329699 (case), Lot Number 21IME955A; 11) Pack Number DYNJ42912F: UDI/DI 10193489785753 (each) 40193489785754 (case), Lot Number 23LBU921Z; 12) Pack Number DYNJ35643B: UDI/DI 10193489223712 (each) 40193489223713 (case), Lot Number 21BBG490A; 13) Pack Number DYNJ0367643Q: UDI/DI 10193489648614 (each) 40193489648615 (case), Lot Number 23EBE428A; 14) Pack Number PHS616026002A: UDI/DI 10889942429370 (each) 40889942429371 (case), Lot Number 23BBS889A; 15) Pack Number DYNJ24542L: UDI/DI 10193489651119 (each) 40193489651110 (cas

UPC codes

10889942474639, 40889942474630, 10889942806683, 40889942806684, 10193489505634, 40193489505635, 10889942802012, 40889942802013, 10884389722145, 40884389722146, 10888277011298, 40888277011299, 10889942745746, 40889942745747, 10193489541106, 40193489541107, 10889942965021, 40889942965022, 10193489329698, 40193489329699, 10193489785753, 40193489785754, 10193489223712, 40193489223713, 10193489648614, 40193489648615, 10889942429370, 40889942429371, 10193489651119, 40193489651110

Source

Official record: FDA (Device enforcement)

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

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