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

MEDLINE INDUSTRIES, LP - Northfield: Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE PACK, Pack Number DYNJ56987B; 3) ADULT PERC PACK-LF, Pack Number

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: 11,363 units Lot/code info: 1) Pack Number DYNJHS0136D: UDI/DI 10889942848973 (each) 40889942848974 (case), Lot Number 22JBC557Z; 2) Pack Number DYNJ56987B: UDI/DI 10889942868193 (each) 40889942868194 (case), Lot Number 21EBN072A; 3) Pack Number PHS170994005A: UDI/DI 10888277754379 (each) 40888277754370 (case), Lot Number 21IMG402A; 4) Pack Number DYNJ54836B: UDI/DI 10193489574128 (each) 40193489574129 (case), Lot Number 21BBH689A; 5) Pack Number DYNJ58678A: UDI/DI 10888277781207 (each) 40888277781208 (case), Lot Number 21GMF677A; 6) Pack Number DYNJ63532: UDI/DI 10193489748468 (each) 40193489748469 (case), Lot Number 22CMB574A; 7) Pack Number DYNJ81702: UDI/DI 10195327135447 (each) 40195327135448 (case), Lot Number 23CBF695A; 8) Pack Number DYNJ36595D: UDI/DI 10193489928976 (each) 40193489928977 (case), Lot Number 23CBL653A; 9) Pack Number DYNJ69250A: UDI/DI 10195327142315 (each) 40195327142316 (case), Lot Number 23HME051A; 10) Pack Number DYNJ50470C: UDI/DI 10889942922611 (each) 40889942922612 (case), Lot Number 23FME520A; 11) Pack Number DYNJ0115839A: UDI/DI 10193489901764 (each) 40193489901765 (case), Lot Number 23FME450A; 12) Pack Number PHS396134006A: UDI/DI 10889942694303 (each) 40889942694304 (case), Lot Number 23DDA331A; 13) Pack Number DYNJ20114Q: UDI/DI 10193489549249 (each) 40193489549240 (case), Lot Number 22JBF822Z; 14) Pack Number DYNJ0375705L: UDI/DI 10193489544138 (each) 40193489544139 (case), Lot Number 22GBP901M; 15) Pack Number DYNJ38051F: UDI/DI 10193489909319 (each) 40193489909310

UPC codes

10889942848973, 40889942848974, 10889942868193, 40889942868194, 10888277754379, 40888277754370, 10193489574128, 40193489574129, 10888277781207, 40888277781208, 10193489748468, 40193489748469, 10195327135447, 40195327135448, 10193489928976, 40193489928977, 10195327142315, 40195327142316, 10889942922611, 40889942922612, 10193489901764, 40193489901765, 10889942694303, 40889942694304, 10193489549249, 40193489549240, 10193489544138, 40193489544139, 10193489909319, 40193489909310, 10889942213269, 40889942213260, 10889942883271, 40889942883272, 10889942893218, 40889942893219, 10193489292145, 40193489292146, 10884389765067, 40884389765068

Source

Official record: FDA (Device enforcement)

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

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