Medline recalls convenience kits with B. Braun bupivacaine component, urges correction before use
Medline has issued a correction for a range of its convenience surgical kits after discovering that they contain components from B. Braun Medical that include bupivacaine hydrochloride in a dextrose injection.
The FDA has classified this recall as the most serious type, indicating that continued use of the kits without correction could cause serious injury or death.
Affected kits include various hip, knee, and joint kits such as Anterior Hip, C-Section, Total Knee, and Total Hip kits, among others. Medline has asked customers to identify and quarantine any affected inventory.
Customers should place over-labels that instruct removal and disposal of the affected component before using the kits, and submit a recall response form to receive the labels. The company sent a letter on June 6 with detailed lot numbers and instructions.
This writeup was produced by pharmadog from original reporting by fda medwatch.
Original headline: “Convenience Kit Recall: Medline Issues Correction for Convenience Kits Containing B. Braun Bupivacaine Hydrochloride Components”
read at fda medwatch ↗
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