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Medical Malpractice

FDA Issues Class I Recalls for Medline Surgical Kits Containing Bupivacaine Injections

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By People's Justice

What happened

The FDA classified two recalls (Z-2749-2026 and Z-2764-2026) as Class I, the most serious category, for Medline Industries convenience kits — including Total Joint, Total Knee Basic, and Hip CDS-LF kits — that contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The recalled drug component, traced through a supply chain involving B. Braun, ICU Medical, Spectra Medical Devices, and Huons Co., Ltd., may be ineffective.

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Source: api.fda.gov

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