MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036OH; 3) CATH ACCESSO

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: 00-RDF036O, Lot Number 24BMG670; 00-RDF036OH, Lot Number 24BMG670; 00-RDF036OH, Lot Number 22FMH197 ; 00-RDF036OH, Lot Number 22IMC476 ; 00-RDF036OH, Lot Number 22JMD690 ; 00-RDF036OH, Lot Number 22KMB816 ; 00-RDF036OH, Lot Number 22LMB962 ; 00-RDF036OH, Lot Number 23BMA905 ; 00-RDF036OH, Lot Number 23BMH681 ; 00-RDF036OH, Lot Number 23CMG412 ; 00-RDF036OH, Lot Number 23DMI750 ; 00-RDF036OH, Lot Number 23IMD552 ; 00-RDF036OH, Lot Number 23KMD849 ; 0M-CP31433J, Lot Number 24DBD373; ART1210, Lot Number 2023121890; BM17BAD, Lot Number 22FBA406; BM17BAD, Lot Number 22EBJ428; CVI4970, Lot Number 2023121880; DYNDH1129, Lot Number 2019012450; DYNDH1134, Lot Number 2019012450; DYNDH1228, Lot Number 23JBW148; DYNDH1228, Lot Number 23HBW751; DYNDH1228, Lot Number 23FBU652; DYNDH1228, Lot Number 23DBK822; DYNDH1228, Lot Number 23JBW148; DYNDH1228, Lot Number 23HBW751; DYNDH1228, Lot Number 23FBU652; DYNDH1228, Lot Number 23DBK822; DYNDH1540A, Lot Number 2023091990; DYNDH1827, Lot Number 24BMB809; DYNDH1932, Lot Number 2023121180; DYNDL1462B, Lot Number 2019012450; DYNJ0105963Q, Lot Number 22GMH630; DYNJ0105963Q, Lot Number 22EMG581; DYNJ0105963Q, Lot Number 22CMI727; DYNJ0105963Q, Lot Number 22CMA702; DYNJ0161912G, Lot Number 23KDB964; DYNJ0173400P, Lot Number 21FMC951; DYNJ0173400P, Lot Number 21DME907; DYNJ0173400P, Lot Number 21CMB877; DYNJ0173400P, Lot Number 21AMB468; DYNJ0173400P, Lot Number 20LME686; DYNJ0173400P, Lot Number 20LMC387; DYNJ0173400P, Lot Number 20JMC557; DYNJ017340

Source

Official record: FDA (Device enforcement) ↗

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