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FDAApril 21, 2026device

Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300, CVC KIT: 14 GA X 6 IN/CK-04711

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

What to do

FDA enforcement status: Ongoing

Brands named

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UPCs

10801902121582108019021932751080190212163620801902118787

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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