MEDLINE INDUSTRIES, LP - Northfield: Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2) BREAST SURGERY FOAKS, Pack Number DYNJ63577C; 3) CHEST BREAST -LF, Pack Number D

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: 1228 units Lot/code info: 1) Pack Number DYNJ0956628O: UDI/DI 10193489785869 (each) 40193489785860 (case), Lot Number 21BBH575A; 2) Pack Number DYNJ63577C: UDI/DI 10193489267143 (each) 40193489267144 (case), Lot Number 21BBI089A; 3) Pack Number DYNJCEN04C: UDI/DI 10193489805413 (each) 40193489805414 (case), Lot Number 21BBI544A; 4) Pack Number DYNJ60669G: UDI/DI 10889942794942 (each) 40889942794943 (case), Lot Number 21EME131A; 5) Pack Number DYNJ64670B: UDI/DI 10889942575701 (each) 40889942575702 (case), Lot Number 21IME484A; 6) Pack Number DYNJ40647G: UDI/DI 10193489270976 (each) 40193489270977 (case), Lot Number 21IMH836A; 7) Pack Number DYNJ0665560D: UDI/DI 10195327089795 (each) 40195327089796 (case), Lot Number 22CMB464A; 8) Pack Number DYNJ40356A: UDI/DI 10193489228335 (each) 40193489228336 (case), Lot Number 22JBF484Z; 9) Pack Number DYNJ0252232U: UDI/DI 10195327217334 (each) 40195327217335 (case), Lot Number 22JBG465Z; 10) Pack Number DYNJ60232A: UDI/DI 10195327222451 (each) 40195327222452 (case), Lot Number 22JBN921Z; 11) Pack Number DYNJ43576A: UDI/DI 10193489920116 (each) 40193489920117 (case), Lot Number 22JBU153Z; 12) Pack Number DYNJ00264L: UDI/DI 10193489801866 (each) 40193489801867 (case), Lot Number 22JBU265A; 13) Pack Number DYNJ49742B: UDI/DI 10195327210267 (each) 40195327210268 (case), Lot Number 22JBV346A; 14) Pack Number DYNJ14039B: UDI/DI 10193489324495 (each) 40193489324496 (case), Lot Number 22JBW642A; 15) Pack Number DYNJ09866U: UDI/DI 10195327230081 (each) 40195327230082 (ca

UPC codes

10193489785869, 40193489785860, 10193489267143, 40193489267144, 10193489805413, 40193489805414, 10889942794942, 40889942794943, 10889942575701, 40889942575702, 10193489270976, 40193489270977, 10195327089795, 40195327089796, 10193489228335, 40193489228336, 10195327217334, 40195327217335, 10195327222451, 40195327222452, 10193489920116, 40193489920117, 10193489801866, 40193489801867, 10195327210267, 40195327210268, 10193489324495, 40193489324496, 10195327230081, 40195327230082, 10193489276510, 40193489276511

Source

Official record: FDA (Device enforcement) ↗

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