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FDA (Device enforcement)Recalled 2024-04-08class ii

MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience kits, labeled as: 1) NERVE STIMULATOR, Pack Number CDS981579O ; 2) DR DIULUS INJECTION PACK, Pack Number DYNDA2391; 3) BLOCK KIT , 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: CDS981579O , Lot Number 21JBM647 ; CDS981579O , Lot Number 21JBQ860 ; CDS981579O , Lot Number 22CBX741 ; CDS981579O , Lot Number 19EBL586 ; CDS981579O , Lot Number 19GBJ538 ; CDS981579O , Lot Number 19IBH976 ; CDS981579O , Lot Number 19JBZ536 ; CDS981579O , Lot Number 19KBB918 ; CDS981579O , Lot Number 20ABP061 ; CDS981579O , Lot Number 20BBA647 ; CDS981579O , Lot Number 20DBM006 ; CDS981579O , Lot Number 20FBS525 ; CDS981579O , Lot Number 21ABO831 ; CDS981579O , Lot Number 21BBI363 ; CDS981579O , Lot Number 21CBI409 ; CDS981579O , Lot Number 21DBG604 ; CDS981579O , Lot Number 21FBC673 ; DYNDA2391, Lot Number 21JBR496 ; DYNDA2508, Lot Number 19FBY839 ; DYNDL1389, Lot Number 22FMG166; DYNDL1389, Lot Number 22DMC258; DYNDL1389, Lot Number 22NBA716; DYNJ0117039, Lot Number 19ALA192 ; DYNJ0117039, Lot Number 19FLA299 ; DYNJ0117039, Lot Number 19LLA121 ; DYNJ0117039, Lot Number 20ALA869 ; DYNJ0117039, Lot Number 20CLA195 ; DYNJ0117039, Lot Number 20GLA412 ; DYNJ0117039, Lot Number 20ILA113 ; DYNJ0117039, Lot Number 20JLA806 ; DYNJ0117039, Lot Number 20KLA286 ; DYNJ0117039, Lot Number 21ALA145 ; DYNJ0134147D , Lot Number 21JBP263 ; DYNJ0134147D , Lot Number 22ABI678 ; DYNJ0134147D , Lot Number 22EMB713 ; DYNJ0134147D , Lot Number 23CMA573 ; DYNJ0134147D , Lot Number 23GMB375 ; DYNJ0134147D , Lot Number 19AKA640 ; DYNJ0134147D , Lot Number 19BKA636 ; DYNJ0134147D , Lot Number 19CKD047 ; DYNJ0134147D , Lot Number 19EKC644 ; DYNJ0134147D , Lot Number 19GKC561 ; DYNJ0134147D , Lot Numb

Source

Official record: FDA (Device enforcement)

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

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