MEDLINE INDUSTRIES, LP - Northfield: Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number

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. Quantity: 1,679,067 units in total Lot/code info: 00-398281J , Lot Number 19FBL693 ; 00-398281J , Lot Number 19HBQ768 ; 00-398281J , Lot Number 19IBJ984 ; 00-398281J , Lot Number 19JBM853 ; 00-398650AG, Lot Number 19ABM946 ; 00-398650AG, Lot Number 19BBS748 ; 00-398650AG, Lot Number 19CBJ825 ; 00-398650AG, Lot Number 19DBR708 ; 00-398650AG, Lot Number 19FBR243 ; 00-398650AG, Lot Number 19IBV635 ; 00-398650AG, Lot Number 19KBL462 ; 00-398650AG, Lot Number 20MBA140 ; 00-398650AG, Lot Number 20EBE408 ; 00-398650AG, Lot Number 20FBJ771 ; 00-398650AG, Lot Number 20HBI575 ; 00-398650AG, Lot Number 20JBJ100 ; 00-398650AG, Lot Number 21ABP363 ; 00-398650AG, Lot Number 21ABQ027 ; 00-398650AI, Lot Number 21FBT441 ; 00-398650AI, Lot Number 21IBH355 ; 00-398650AI, Lot Number 21KBM869 ; 00-398650AI, Lot Number 21LBH937 ; 00-398650AI, Lot Number 22BBA596 ; 00-398650AI, Lot Number 22CBY494 ; 00-398650AI, Lot Number 22DBQ496 ; 00-398650AI, Lot Number 22FBL546 ; 00-398650AI, Lot Number 22GBJ321 ; 00-398650AI, Lot Number 22JBE607 ; 00-398650AI, Lot Number 22JBE609 ; 00-398650AI, Lot Number 21EBB527 ; 00-398712S , Lot Number 19KMA101 ; 00-398712S , Lot Number 19LMB722 ; 00-398712S , Lot Number 20CMA260 ; 00-398712S , Lot Number 20CMC911 ; 00-398712S , Lot Number 20FMA921 ; 00-398712S , Lot Number 20GMB435 ; 00-398712S , Lot Number 20IMA653 ; 00-398712S , Lot Number 20KMA809 ; 00-398712S , Lot Number 20LMD895 ; 00-398712S , Lot Number 21CMD722 ; 00-398712S , Lot Number 21EMF323 ; 00-398712S , Lot Number 21HMB142 ; 00-398712S , Lot Number 21IMB8

Source

Official record: FDA (Device enforcement) ↗

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