United StatesMedline Industries is recalling multiple Medline Convenience Kits—including models DYNJ905503F, DYNJ905503G, CDS840144Q and numerous other “Open Heart” and central-line kit model numbers and listed UDI/lot identifiers—that contain Arrow Kits and Sets with Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP. The kits were recalled because quality issues were identified during a recent FDA inspection of the supplier; they were distributed nationwide in the United States.
What's being recalled
Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP; 2) DYNJ905503G, Model Number: CV ANESTHESIA - ROOM SET UP
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, Model Number: CDS982269N; 5) OPEN HEART ANESTHESIA PACK, Model Number: CDS983849G; 6) OPEN HEART ACCESSORY CDS, Model Number: CDS984289L; 7) OPEN HEART A, Model Number: CDS985105Q; 8) OPEN HEART PART 2, Model Number: DYNJ901075R; 9) VPH OPEN HEART, Model Number: DYNJ902664L; 10) HEART A, Model Number: DYNJ903465I; 11) HEART, Model Number: DYNJ903822F; 12) OPEN HEART BASIC B, Model Number: DYNJ904311F; 13) SM OPEN HEART PACK A&B, Model Number: DYNJ904749J; 14) OPEN HEART ANESTHESIA ICC-B, Model Number: DYNJ905567B; 15)…
Medline Convenience Kits: 1) DRAWER 6 CENTRAL LINE INSERTIO, Model Number: ACC011142; 2) CENTRAL AND ARTERIAL LINE TOTE, Model Number: DYNJ8407
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
Recalling firm: Medline Industries, LP, Northfield, IL, United States.
How to identify it
1) DYNJ905503F, UDI-DI: 10193489967272(each), 40193489967273(case), Lot Number: 24GBR740; 2) DYNJ905503F, UDI-DI: 10193489967272(each), 40193489967273(case), Lot Number: 24JBP984; 3) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 26DBJ110; 4) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25ABJ069; 5) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25ABL749; 6) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25CBB762; 7) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25DBG799; 8) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25EBM994; 9) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25GBW226; 10) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25LBA950; 11) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25LBT019; 12) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 26ABH519; 13) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 26ABT315; 14) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 26BBQ338 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…
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)