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
Medline Industries, LP
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. FDA Class I recall.
The remedy
Follow FDA guidance
About this recall
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
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 1) ACC010890Model UDI-DI: 10198459139833(each)Model 40198459139834(case)Model Lot Number: 25BDA811Model 2) ACC010890Model Lot Number: 25DDB415Model 3) ACC010890Model Lot Number: 25DDC095Model 4) DYNJ910066Model UDI-DI: 10195327565596(each)Model 40195327565597(case)Model Lot Number: 25ADB324Model 5) DYNJ910066Model Lot Number: 25FDB473Model 6) DYNJ910066Model Lot Number: 25GDA336Model 7) DYNJ910066UPC 10198459139833UPC 40198459139834UPC 10195327565596UPC 40195327565597UPC 10198459019951UPC 40198459019952Would you have heard about this one?
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