MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T; 2) TOTAL KNEE-LF, Medline kit SKU CDSOPT590U; 3) TOTAL KNEE CDS, Medline kit SKU CDS983930J; 4) HIP CDS-LF, Medline kit SKU CDS984556L; 5) HIP CDS-LF, Medline kit SKU CDS984556M; 6) TOTAL KNEE PACK, M
Medline Industries, LP
The hazard
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness. FDA Class I recall.
The remedy
Follow FDA guidance
About this recall
MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T; 2) TOTAL KNEE-LF, Medline kit SKU CDSOPT590U; 3) TOTAL KNEE CDS, Medline kit SKU CDS983930J; 4) HIP CDS-LF, Medline kit SKU CDS984556L; 5) HIP CDS-LF, Medline kit SKU CDS984556M; 6) TOTAL KNEE PACK, Medline kit SKU DYNJ905162Q.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model Medline kit SKU CDSOPT590TModel UDI/DI 10195327555009 (each) 40195327555000 (case)Model Kit Lot Number 24GDA740Model Medline kit SKU CDSOPT590UModel UDI/DI 10198459180255 (each) 40198459180256 (case)Model Kit Lot Number 26EDA279Model Kit Lot Number 26BDB734Model Kit Lot Number 26ADA474Model Kit Lot Number 25LDA001Model Kit Lot Number 25KDB325Model Kit Lot Number 25GDB517Model Kit Lot Number 25FDB017UPC 10195327555009UPC 40195327555000UPC 10198459180255UPC 40198459180256UPC 10193489512298UPC 40193489512299UPC 10195327554996UPC 40195327554997Would you have heard about this one?
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