MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience kits labeled as: 1) BIOPSY PROCEDURE PACK, Pack Number 00-400162J; 2) BIOPSY PROCEDURE TRAY , Pack Number 00-400405C ; 3) BIOPSY DRAPE PACK , P

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: 00-400162J, Lot Number 24BMJ154; 00-400162J , Lot Number 21HBM269 ; 00-400162J , Lot Number 21IBK734 ; 00-400162J , Lot Number 21VBB786 ; 00-400162J , Lot Number 21KBS936 ; 00-400162J , Lot Number 21LBA763 ; 00-400162J , Lot Number 22ABN222 ; 00-400162J , Lot Number 19ABM483 ; 00-400162J , Lot Number 19BBI451 ; 00-400162J , Lot Number 19CBM173 ; 00-400162J , Lot Number 19DBL959 ; 00-400162J , Lot Number 22FBO944 ; 00-400162J , Lot Number 19FBG533 ; 00-400162J , Lot Number 22JBB402 ; 00-400162J , Lot Number 19TBB201 ; 00-400162J , Lot Number 22KBV632 ; 00-400162J , Lot Number 19JBD745 ; 00-400162J , Lot Number 19KBI828 ; 00-400162J , Lot Number 19LBK452 ; 00-400162J , Lot Number 23CBO907 ; 00-400162J , Lot Number 19LBY367 ; 00-400162J , Lot Number 20ABQ389 ; 00-400162J , Lot Number 23FBG349 ; 00-400162J , Lot Number 20CBV380 ; 00-400162J , Lot Number 20DBI320 ; 00-400162J , Lot Number 23IBF372 ; 00-400162J , Lot Number 20FBQ675 ; 00-400162J , Lot Number 20GBO378 ; 00-400162J , Lot Number 20JBH095 ; 00-400162J , Lot Number 20JBL452 ; 00-400162J , Lot Number 20JBX151 ; 00-400162J , Lot Number 20KBZ223 ; 00-400162J , Lot Number 20XBA215 ; 00-400162J , Lot Number 21DBB680 ; 00-400162J , Lot Number 24AMB898 ; 00-400405C , Lot Number 21KBM812 ; 00-400405C , Lot Number 21LBT408 ; 00-400405C , Lot Number 21LBT899 ; 00-400405C , Lot Number 19ABL059 ; 00-400405C , Lot Number 19BBB783 ; 00-400405C , Lot Number 19CBC868 ; 00-400405C , Lot Number 19KBY105 ; 00-400405C , Lot Number 19LBB184

Source

Official record: FDA (Device enforcement) ↗

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