MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience kits labeled as: 1) ECMO INSERTION BUNDLE W/O CANNULA, Pack Number CVI4915; 2) PORT ACCESS TRAY, Pack Number DYNDC1318D; 3) KNEE ARTHROSCOPY PA

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: CVI4915, Lot Number 2022103180; DYNDC1318D, Lot Number 2019012590; DYNJ0101308C , Lot Number 19BKC672 ; DYNJ04047C , Lot Number 21FBN548 ; DYNJ04047C , Lot Number 21GBL027 ; DYNJ04047C , Lot Number 21IBX365 ; DYNJ04047C , Lot Number 22ABM052 ; DYNJ04047C , Lot Number 19ABD460 ; DYNJ04047C , Lot Number 22CBP491 ; DYNJ04047C , Lot Number 22OBI898 ; DYNJ04047C , Lot Number 19FBD994 ; DYNJ04047C , Lot Number 22IBH860 ; DYNJ04047C , Lot Number 22IBJ054 ; DYNJ04047C , Lot Number 22LBR925 ; DYNJ04047C , Lot Number 19VBB656 ; DYNJ04047C , Lot Number 23ABS681 ; DYNJ04047C , Lot Number 19KBC727 ; DYNJ04047C , Lot Number 19KBF911 ; DYNJ04047C , Lot Number 20DBF312 ; DYNJ04047C , Lot Number 20JBC775 ; DYNJ17507B , Lot Number 19JDB044 ; DYNJ17507B , Lot Number 20EDA752 ; DYNJ17507B , Lot Number 20FDB395 ; DYNJ17507B , Lot Number 20IDB921 ; DYNJ17507B , Lot Number 20JDA956 ; DYNJ17507B , Lot Number 20LDB169 ; DYNJ17507B , Lot Number 21GDA031 ; DYNJ17507B , Lot Number 21HDB179 ; DYNJ17507B , Lot Number 21JDC732 ; DYNJ17507B , Lot Number 23ADA442 ; DYNJ41737C , Lot Number 21FBK597 ; DYNJ41737C , Lot Number 21GBM874 ; DYNJ41737C , Lot Number 21IBD142 ; DYNJ41737C , Lot Number 21JBB598 ; DYNJ41737C , Lot Number 21JBB602 ; DYNJ41737C , Lot Number 21WBA194 ; DYNJ41737C , Lot Number 21LBP147 ; DYNJ41737C , Lot Number 22ABE433 ; DYNJ41737C , Lot Number 19ABJ657 ; DYNJ41737C , Lot Number 19CBB947 ; DYNJ41737C , Lot Number 22OBI031 ; DYNJ41737C , Lot Number 19CBO914 ; DYNJ41737C , Lot Number 19DBC69

Source

Official record: FDA (Device enforcement) ↗

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