Medline Industries, LP: Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2) OPEN HEART, Model Number: CDS840150W; 3) OPEN HEART ADULT, Model Number: CDS840396AA; 4) CABG A CDS, M

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: 6775 units Lot/code info: 1) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 24LBH805; 2) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 24HBM100; 3) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 25ABR195; 4) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 25EBS810; 5) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 25FBS936; 6) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 25GBX096; 7) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 25IBT859; 8) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 24KBE879; 9) CDS840144R, UDI-DI: 10198459561627(each), 40198459561628(case), Lot Number: 26DBF234; 10) CDS840144R, UDI-DI: 10198459561627(each), 40198459561628(case), Lot Number: 26ABG176; 11) CDS840144R, UDI-DI: 10198459561627(each), 40198459561628(case), Lot Number: 26ABK484; 12) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24HBQ201; 13) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 25CBD369; 14) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 25DBL498; 15) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 24LBD200; 16) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 24LBD223; 17) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), L

UPC codes

10195327263102, 40195327263103, 10198459561627, 40198459561628, 10195327648046, 40195327648047, 10198459112386, 40198459112387, 10198459303029, 40198459303020, 10198459348686, 40198459348687, 10198459468742, 40198459468743, 10198459639494, 40198459639495, 10195327574932, 40195327574933, 10198459022531, 40198459022532, 10198459245237, 40198459245238, 10198459370991, 40198459370992, 10198459478420, 40198459478421, 10198459520440, 40198459520441, 10195327352998, 40195327352999, 10195327650148, 40195327650149, 10195327439064, 40195327439065, 10198459118548, 40198459118549, 10198459256769, 40198459256760, 10198459418143, 40198459418144

Source

Official record: FDA (Device enforcement) ↗

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