MEDLINE INDUSTRIES, LP - Northfield: Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G; 2) ARTERIOGRAM PACK, Pack Number DYNJ64332; 3) ARTHRO PACK-LF, 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: 14589 units Lot/code info: 1) Pack Number DYNJ55316G: UDI/DI 10889942278022 (each) 40889942278023 (case), Lot Number 20BDA583A; 2) Pack Number DYNJ64332: UDI/DI 10889942692262 (each) 40889942692263 (case), Lot Number 20BDB394A; 3) Pack Number DYNJ38748F: UDI/DI 10193489275063 (each) 40193489275064 (case), Lot Number 20BDB587A; 4) Pack Number DYNJ38748F: UDI/DI 10889942524334 (each) 40889942524335 (case), Lot Number 20BDB606A; 5) Pack Number DYNJ65817: UDI/DI 10193489744910 (each) 40193489744911 (case), Lot Number 20EBL095A; 6) Pack Number DYNDH1937: UDI/DI 10193489773088 (each) 40193489773089 (case), Lot Number 20FBS286Z; 7) Pack Number DYNJ0809731F: UDI/DI 10193489369892 (each) 40193489369893 (case), Lot Number 20FBS559A; 8) Pack Number DYNJ66665: UDI/DI 10888277546394 (each) 40888277546395 (case), Lot Number 20FMA565A; 9) Pack Number DYNJ38716C: UDI/DI 10193489706796 (each) 40193489706797 (case), Lot Number 20GBA802Z; 10) Pack Number DYNJ33639J: UDI/DI 10193489783247 (each) 40193489783248 (case), Lot Number 20GKA136A; 11) Pack Number DYNJ37707D: UDI/DI 10193489258936 (each) 40193489258937 (case), Lot Number 20HKB321A; 12) Pack Number DYNJ38914A: UDI/DI 10193489265651 (each) 40193489265652 (case), Lot Number 20HKB355A; 13) Pack Number DYNJ64526A: UDI/DI 10193489531589 (each) 40193489531580 (case), Lot Number 20HMC644A; 14) Pack Number DYNJ62755B: UDI/DI 10193489296792 (each) 40193489296793 (case), Lot Number 20HMD066A; 15) Pack Number DYNJ61634B: UDI/DI 10888277756168 (each) 40888277756169 (case), Lot

UPC codes

10889942278022, 40889942278023, 10889942692262, 40889942692263, 10193489275063, 40193489275064, 10889942524334, 40889942524335, 10193489744910, 40193489744911, 10193489773088, 40193489773089, 10193489369892, 40193489369893, 10888277546394, 40888277546395, 10193489706796, 40193489706797, 10193489783247, 40193489783248, 10193489258936, 40193489258937, 10193489265651, 40193489265652, 10193489531589, 40193489531580, 10193489296792, 40193489296793, 10888277756168, 40888277756169, 10193489366815, 40193489366816, 10193489718577, 40193489718578, 10193489397598, 40193489397599, 10193489338829, 40193489338820, 10193489408188, 40193489408189

Source

Official record: FDA (Device enforcement) ↗

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