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FDAAugust 6, 2021device

Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous infusion capabilities (3 lumens), Femoral Vein Insertion Only, Sterile EO, Rx only, UDI: (01)008491110 7550 3

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

00849111075503

Recall history

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

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Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous infusion capabilities (3 lumens), Femoral Vein Insertion Only, Sterile EO, Rx only, UDI: (01)008491110 7550 3 — Recall Details · AllClear