MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience kits labeled as: 1) MYELOGRAM PACK, Pack Number 00-399025L ; 2) BIOPSY PROCEDURE PACK , Pack Number 00-399227G ; 3) BIOPSY PROCEDURE PACK, Pack

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. Lot/code info: 00-399025L , Lot Number 23LMB058 ; 00-399025L , Lot Number 23LMG684 ; 00-399025L , Lot Number 23LMH827 ; 00-399025L , Lot Number 24AMC410 ; 00-399025L , Lot Number 19ELA658 ; 00-399025L , Lot Number 19KLA410 ; 00-399025L , Lot Number 20BLA276 ; 00-399025L , Lot Number 20CLA517 ; 00-399025L , Lot Number 20GLA372 ; 00-399025L , Lot Number 20JLA514 ; 00-399025L , Lot Number 21ELA301 ; 00-399025L , Lot Number 21HLA415 ; 00-399025L , Lot Number 21JLA793 ; 00-399025L , Lot Number 22CLA145 ; 00-399025L , Lot Number 22ELA199 ; 00-399025L , Lot Number 22ELA628 ; 00-399025L , Lot Number 22JLA233 ; 00-399025L , Lot Number 23ALA823 ; 00-399025L , Lot Number 23ELA753 ; 00-399025L , Lot Number 23ELB229 ; 00-399025L , Lot Number 23JLA541 ; 00-399025L , Lot Number 23KLA374 ; 00-399227G , Lot Number 21FBH746 ; 00-399227G , Lot Number 21HBQ582 ; 00-399227G , Lot Number 21KBJ142 ; 00-399227G , Lot Number 21LBA848 ; 00-399227G , Lot Number 19ABX389 ; 00-399227G , Lot Number 22OBD945 ; 00-399227G , Lot Number 19FBF786 ; 00-399227G , Lot Number 19FBV846 ; 00-399227G , Lot Number 22HBG087 ; 00-399227G , Lot Number 19HBD311 ; 00-399227G , Lot Number 22JBP132 ; 00-399227G , Lot Number 19IBR526 ; 00-399227G , Lot Number 19KBL802 ; 00-399227G , Lot Number 23CBG549 ; 00-399227G , Lot Number 19LBY409 ; 00-399227G , Lot Number 20ABD605 ; 00-399227G , Lot Number 23FBQ709 ; 00-399227G , Lot Number 20CBV379 ; 00-399227G , Lot Number 23HBW465 ; 00-399227G , Lot Number 20EBL397 ; 00-399227G , Lot Number 20GBW3

Source

Official record: FDA (Device enforcement) ↗

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