Medline Industries, LP: 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: DYNJ9855016

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide. Quantity: 503 units Lot/code info: 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

UPC codes

10198459139833, 40198459139834, 10195327565596, 40195327565597, 10198459019951, 40198459019952, 10198459571374, 40198459571375

Source

Official record: FDA (Device enforcement) ↗

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