Official recall notice

FDA DeviceClass INotable

FDA Recall: MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N

Recall date
2026-07-29
FDA class
Class I

Why it was recalled

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.

Product description

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.

Affected products

UDI/DI 10198459266621 (each) 40198459266622 (case), Lot Numbers: 26EDA285, 26DDA718, 26BDB740, 26ADB079, 26ADA161, 25KDB472, 25GDA213.

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