MEDLINE INDUSTRIES, LP - Northfield: Medline procedural kits labeled as: 1) OPEN HEART PEDS, Pack Number CDS981050Q; 2) OPEN HEART CDS, Pack Number CDS982411N; 3) OPEN HEART, Pack Number CDS983348AA;

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 Lot/code info: CDS981050Q , Lot Numbers : 23IBJ172 ; CDS982411N , Lot Numbers : 23IBH624 ; CDS982411N , Lot Numbers : 23IBI963 ; CDS983348AA, Lot Numbers : 23FBN637 ; CDS983348AA, Lot Numbers : 24ABM288 ; CDS983348AA, Lot Numbers : 24ABR888 ; CDS983348X , Lot Numbers : 22GBA977 ; CDS983348X , Lot Numbers : 22KBB264 ; CDS983348Y , Lot Numbers : 23BBR849 ; CDS983348Y , Lot Numbers : 23CBM949 ; CDS983348Y , Lot Numbers : 23DBB694 ; CDS984206R , Lot Numbers : 22GBP993 ; CDS984206R , Lot Numbers : 22HBU408 ; CDS984206R , Lot Numbers : 22KLA374 ; CDS984206R , Lot Numbers : 22KLB170 ; CDS984206R , Lot Numbers : 22LLA600 ; CDS984206R , Lot Numbers : 23ALA250 ; CDS984206R , Lot Numbers : 23ALA462 ; CDS984206R , Lot Numbers : 23ALA777 ; CDS984206R , Lot Numbers : 23BLA402 ; CMPJ01037P , Lot Numbers : 23HBT114 ; CMPJ02162I , Lot Numbers : 23HBT075 ; CMPJ03510J , Lot Numbers : 22GBD932 ; CMPJ03510J , Lot Numbers : 22GBK674 ; CMPJ03510J , Lot Numbers : 22JLA999 ; CMPJ03510J , Lot Numbers : 22KLA443 ; CMPJ03510J , Lot Numbers : 22LLA230 ; CMPJ03510J , Lot Numbers : 22LLA577 ; CMPJ03510J , Lot Numbers : 23ALA797 ; CMPJ06631C , Lot Numbers : 23HBQ375 ; CMPJ06631C , Lot Numbers : 23HBU697 ; CMPJ08949F , Lot Numbers : 23HBT997 ; CMPJ09225F , Lot Numbers : 23HBP652 ; CMPJ09236D , Lot Numbers : 22GBG807 ; CMPJ09236F , Lot Numbers : 22HBN769 ; CMPJ09236F , Lot Numbers : 22HBY712 ; CMPJ09236F , Lot Numbers : 23FBF790 ; CMPJ09236F , Lot Numbers : 23FBM695 ; CMPJ09400C , Lot Numbers : 23HBZ030 ; CMPJ10797B , Lot N

Source

Official record: FDA (Device enforcement) ↗

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