MEDLINE INDUSTRIES, LP - Northfield: Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DYNJ0131782J; 3) CABG, Pack Number DYNJ906462B; 4)

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: 3860 units Lot/code info: 1) Pack Number DYNJ80088: UDI/DI 10195327010522 (each) 40195327010523 (case), Lot Number 23DBG477A; 2) Pack Number DYNJ0131782J: UDI/DI 10195327467548 (each) 40195327467549 (case), Lot Number 23LMD975A; 3) Pack Number DYNJ906462B: UDI/DI 10195327057886 (each) 40195327057887 (case), Lot Number 22GBV822Z; 4) Pack Number DYNJ0261346U: UDI/DI 10195327055967 (each) 40195327055968 (case), Lot Number 22GMB113A; 5) Pack Number DYNJ42997C: UDI/DI 10193489988420 (each) 40193489988421 (case), Lot Number 21JMG551A; 6) Pack Number DYNJ61256A: UDI/DI 10193489694918 (each) 40193489694919 (case), Lot Number 23JBH403A; 7) Pack Number DYNJ61527: UDI/DI 10193489578881 (each) 40193489578882 (case), Lot Number 21LBJ158A; 8) Pack Number DYNJ53642C: UDI/DI 10193489721607 (each) 40193489721608 (case), Lot Number 24AMF039A; 9) Pack Number DYNJ49635F: UDI/DI 10195327191405 (each) 40195327191406 (case), Lot Number 23LMF122A; 10) Pack Number DYNJ0810062AI: UDI/DI 10193489866049 (each) 40193489866040 (case), Lot Number 22CMB582A; 11) Pack Number DYNJ44857T: UDI/DI 10195327221959 (each) 40195327221950 (case), Lot Number 22JBD481Z; 12) Pack Number DYNJ59830A: UDI/DI 10193489570236 (each) 40193489570237 (case), Lot Number 21EMF434A; 13) Pack Number SYNJ10304B: UDI/DI 10193489786965 (each) 40193489786966 (case), Lot Number 21LBD584A; 14) Pack Number DYNJ53854A: UDI/DI 10193489631517 (each) 40193489631518 (case), Lot Number 21GMB561A; 15) Pack Number DYNJ30217G: UDI/DI 10193489922141 (each) 40193489922142 (ca

UPC codes

10195327010522, 40195327010523, 10195327467548, 40195327467549, 10195327057886, 40195327057887, 10195327055967, 40195327055968, 10193489988420, 40193489988421, 10193489694918, 40193489694919, 10193489578881, 40193489578882, 10193489721607, 40193489721608, 10195327191405, 40195327191406, 10193489866049, 40193489866040, 10195327221959, 40195327221950, 10193489570236, 40193489570237, 10193489786965, 40193489786966, 10193489631517, 40193489631518, 10193489922141, 40193489922142, 10889942621552, 40889942621553, 10195327332273, 40195327332274, 10193489902044, 40193489902045, 10193489401110, 40193489401111, 10193489927559, 40193489927550

Source

Official record: FDA (Device enforcement) ↗

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