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FDAAugust 6, 2021device

ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only, UDI: (01)00849111075190

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

The hazard

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

What to do

FDA enforcement status: Terminated

Brands named

zoll circulationzoll

UPCs

00849111075190

Recall history

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

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