Zoll ICY intravascular heat exchange catheter kit recalled for potential leaks
ZOLL Circulation is recalling 33,066 units of the Zoll REF 8700-0782-40 ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall for a risk-of-harm product—an intravascular catheter with potential leaks—where no illnesses or injuries are reported in the source text. The potential for leaks in a critical therapeutic device poses significant clinical risk despite the absence of confirmed adverse events.
Plain-English summary
ZOLL Circulation, Inc. is recalling the Zoll REF 8700-0782-40 (IC-3893AE) ICY Intravascular Heat Exchange Catheter Kit due to a labeling update concerning potential leaks from the catheter or start-up kit (SUK) tubing.
The recalled product is a sterile, heparin-coated intravascular heat exchange catheter kit with central venous infusion capabilities (3 lumens), intended for therapeutic applications. All lots of this device are affected, comprising 33,066 units distributed worldwide, including nationwide distribution across the United States and internationally to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand.
Healthcare facilities and patients who have received this device should contact ZOLL Circulation, Inc. regarding the potential leak hazard and any necessary follow-up or corrective actions.
The recalled product
- Product
- Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075251
- Manufacturer
- ZOLL Circulation, Inc.
- Hazard
- catheter-leak
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Distributed nationwide across the United States.
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