MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience kits labeled as: 1) GB GENERAL ENDO , Pack Number CDS984155G ; 2) BAPTIST FLOYD ENDO GI KIT , Pack Number DYKE1455B; 3) ENDO KIT, Pack Number D

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: CDS984155G , Lot Number 21GBT672 ; CDS984155G , Lot Number 21JBH429 ; CDS984155G , Lot Number 21LBP590 ; CDS984155G , Lot Number 22CBJ567 ; CDS984155G , Lot Number 22FBB170 ; CDS984155G , Lot Number 22GBB172 ; CDS984155G , Lot Number 22GBW487 ; CDS984155G , Lot Number 22HBN079 ; CDS984155G , Lot Number 22IBR934 ; CDS984155G , Lot Number 19LBO258 ; CDS984155G , Lot Number 20BBE301 ; CDS984155G , Lot Number 20EBC706 ; CDS984155G , Lot Number 20EBS188 ; CDS984155G , Lot Number 20GBA894 ; CDS984155G , Lot Number 20IBD347 ; CDS984155G , Lot Number 20JBK812 ; CDS984155G , Lot Number 21BBO717 ; CDS984155G , Lot Number 21EBO578 ; DYKE1455B, Lot Number 20GBI602 ; DYKE1487C, Lot Number 22GMD695 ; DYKE1634 , Lot Number 19DAA540 ; DYKE1634 , Lot Number 19DAB449 ; DYKE1634 , Lot Number 19JAA076 ; DYKE1634 , Lot Number 21LBY138 ; DYKE1634 , Lot Number 22ABW321 ; DYKE1634 , Lot Number 22IBN133 ; DYKE1634 , Lot Number 23ABN492 ; DYKE1634 , Lot Number 23EBE760 ; DYKE1634 , Lot Number 20BBY787 ; DYKE1634 , Lot Number 23FBP558 ; DYKE1634 , Lot Number 20EBI139 ; DYKE1634 , Lot Number 23KBU935 ; DYKE1634 , Lot Number 20HBM035 ; DYKE1634 , Lot Number 20IBS530 ; DYKE1634 , Lot Number 20JBF837 ; DYKE1696 , Lot Number 23LMF046 ; DYKE1713 , Lot Number 22ABU757 ; DYKE1713 , Lot Number 22BBY210 ; DYKE1713 , Lot Number 22GBJ615 ; DYKE1713 , Lot Number 22KBC587 ; DYKE1713 , Lot Number 19JBJ509 ; DYKE1713 , Lot Number 23BBL166 ; DYKE1713 , Lot Number 23BBU192 ; DYKE1713 , Lot Number 23EBA547 ; DYKE1713 , L

Source

Official record: FDA (Device enforcement) ↗

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