MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience kits labeled as: 1) ZALE STEREOTACTIC CDS , Pack Number CDS983173G ; 2) ZALE OTOLOGY CDS, Pack Number CDS983181D ; 3) BGMC GENERAL LAPAROSCOPY

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: CDS983173G , Lot Number 21FBQ527 ; CDS983173G , Lot Number 21HBF657 ; CDS983173G , Lot Number 21IBE910 ; CDS983173G , Lot Number 21IBM809 ; CDS983173G , Lot Number 21JBJ185 ; CDS983173G , Lot Number 21KBM498 ; CDS983173G , Lot Number 22ABF773 ; CDS983173G , Lot Number 22BBH011 ; CDS983173G , Lot Number 19ABX210 ; CDS983173G , Lot Number 22OBM500 ; CDS983173G , Lot Number 22EBQ566 ; CDS983173G , Lot Number 19GBS147 ; CDS983173G , Lot Number 19IBG146 ; CDS983173G , Lot Number 19IBJ785 ; CDS983173G , Lot Number 19KBA219 ; CDS983173G , Lot Number 19KBA926 ; CDS983173G , Lot Number 20BBA113 ; CDS983173G , Lot Number 20CBP609 ; CDS983173G , Lot Number 20DBU576 ; CDS983173G , Lot Number 20HBQ718 ; CDS983173G , Lot Number 20KBY137 ; CDS983173G , Lot Number 20LBL243 ; CDS983173G , Lot Number 21BBO662 ; CDS983173G , Lot Number 21EBC912 ; CDS983181D , Lot Number 21FBP606 ; CDS983181D , Lot Number 21FBP608 ; CDS983181D , Lot Number 21GBM695 ; CDS983181D , Lot Number 21IBW768 ; CDS983181D , Lot Number 21KBT227 ; CDS983181D , Lot Number 21KBT228 ; CDS983181D , Lot Number 22ABD357 ; CDS983181D , Lot Number 19ABU206 ; CDS983181D , Lot Number 19BBQ372 ; CDS983181D , Lot Number 19CBK097 ; CDS983181D , Lot Number 22OBL824 ; CDS983181D , Lot Number 19QBA591 ; CDS983181D , Lot Number 19FBV743 ; CDS983181D , Lot Number 19IBF802 ; CDS983181D , Lot Number 19KBD950 ; CDS983181D , Lot Number 19LBK648 ; CDS983181D , Lot Number 20ABR683 ; CDS983181D , Lot Number 20BBA165 ; CDS983181D , Lot Number 20FBI6

Source

Official record: FDA (Device enforcement) ↗

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