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

MEDLINE INDUSTRIES, LP - Northfield: Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number DYNJ0589795V; 2) CATARACT CM-LF, Pack Number DYNJ39921B; 3) CATARACT EYE, Pack Number DYNJ

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: 5,132 units Lot/code info: 1) Pack Number DYNJ0589795V: UDI/DI 10193489826722 (each) 40193489826723 (case), Lot Number 23LMF853A; 2) Pack Number DYNJ39921B: UDI/DI 10195327176365 (each) 40195327176366 (case), Lot Number 24AMI654A; 3) Pack Number DYNJ45662C: UDI/DI 10193489556636 (each) 40193489556637 (case), Lot Number 20EBE340A; 4) Pack Number DYNJ56056B: UDI/DI 10193489635348 (each) 40193489635349 (case), Lot Number 20JKA823A; 5) Pack Number DYNJ56553B: UDI/DI 10193489761962 (each) 40193489761963 (case), Lot Number 21IMG706A; 6) Pack Number DYNJ0417156G: UDI/DI 10889942067428 (each) 40889942067429 (case), Lot Number 22IMG784A; 7) Pack Number DYNJ60411A: UDI/DI 10195327221393 (each) 40195327221394 (case), Lot Number 22IMG811A; 8) Pack Number DYNJ52649F: UDI/DI 10195327357313 (each) 40195327357314 (case), Lot Number 23HME435A; 9) Pack Number DYNJVB1076B: UDI/DI 10195327062736 (each) 40195327062737 (case), Lot Number 23CLA046A; 10) Pack Number DYNJ0317858M: UDI/DI 10889942399789 (each) 40889942399780 (case), Lot Number 22IMD667A; 11) Pack Number DYNJ40081F: UDI/DI 10195327068370 (each) 40195327068371 (case), Lot Number 23IMC700A; 12) Pack Number DYNJ38916B: UDI/DI 10193489969863 (each) 40193489969864 (case), Lot Number 23HMC484A; 13) Pack Number DYNJ46557K: UDI/DI 10193489987225 (each) 40193489987226 (case), Lot Number 23FMF487A; 14) Pack Number DYNJ46557L: UDI/DI 10195327466879 (each) 40195327466870 (case), Lot Number 23LMF146A; 15) Pack Number DYNJ48800C: UDI/DI 10193489602173 (each) 40193489602174 (c

UPC codes

10193489826722, 40193489826723, 10195327176365, 40195327176366, 10193489556636, 40193489556637, 10193489635348, 40193489635349, 10193489761962, 40193489761963, 10889942067428, 40889942067429, 10195327221393, 40195327221394, 10195327357313, 40195327357314, 10195327062736, 40195327062737, 10889942399789, 40889942399780, 10195327068370, 40195327068371, 10193489969863, 40193489969864, 10193489987225, 40193489987226, 10195327466879, 40195327466870, 10193489602173, 40193489602174, 10193489404890, 40193489404891, 10080196818327, 40080196818328, 10888277078758, 40888277078759, 10195327013967, 40195327013968, 10193489442588, 40193489442589

Source

Official record: FDA (Device enforcement)

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

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