The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890; 2) OPEN HEART A OVERHEAD, Model Number: DYNJ910066; 3) OPEN HEART, Model Number: DYNJ9855016V; 4) OPEN HEART, Model Number: DYNJ9855016X
1) ACC010890, UDI-DI: 10198459139833(each), 40198459139834(case), Lot Number: 25BDA811; 2) ACC010890, UDI-DI: 10198459139833(each), 40198459139834(case), Lot Number: 25DDB415; 3) ACC010890, UDI-DI: 10198459139833(each), 40198459139834(case), Lot Number: 25DDC095; 4) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 25ADB324; 5) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 25FDB473; 6) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 25GDA336; 7) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 24FDB427; 8) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25ABH622; 9) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25CBA788; 10) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25CBF665; 11) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25DBR616; 12) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25FBA415; 13) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25HBT666; 14) DYNJ9855016X, UDI-DI: 10198459571374(each), 40198459571375(case), Lot Number: 25KBO109
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.