Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ZOLL Recalled by ZOLL Circulation, Inc. Due to Labeling update concerning potential leaks from the catheter...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ZOLL Circulation, Inc. directly.
Affected Products
ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens) HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075213
Quantity: 6,395 units
Why Was This Recalled?
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About ZOLL Circulation, Inc.
ZOLL Circulation, Inc. has 31 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report