FDA DeviceClass INotable

FDA Recall: MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T

Date: 2026-07-29
Brand: Medline Industries, LP
Category: Medical Device
FDA Class: Class I

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.

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.

Remedy

318 kits

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