FDAApril 21, 2026device

Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F, AHDC KIT: 3L 12 FR X 16 CM/ASK-12123-UOC1, AHDC KIT: 3-L 12 FR X 16 CM/ASK-12123-UPM, AHDC KIT: 3L 12 FR X 20 CM/ASK-15123-UOC1, AHDC KIT: 3-L 12 FR X 20 CM/ASK-15123-UPM, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-P1A, AHDC KIT: 3-L...

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

10801902197136108019021932751080190216852510801902222463108019021599504080190211176830801902111785108019022134161080190221340910801902213430080190219327510801902213423

Recall history

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

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