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FDAAugust 6, 2021device

ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabilities (3 lumens), Use Jugular or Subclavian Vein Approach Only, 20 cm, Sterile EO, Rx Only, UDI:

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

Recall history

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

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