ZOLL ICY Intravascular Catheter Kit: Labeling Update for Potential Leaks
ZOLL Circulation recalls 333 units of its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing. A labeling update addresses the leak risk affecting medical facilities worldwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II device with no reported adverse events or injuries. The hazard—potential leaks—is theoretical. This is primarily a precautionary labeling update addressing a potential risk without documented harm.
Plain-English summary
ZOLL Circulation, Inc. is recalling 333 units of the ZOLL ICY Intravascular Heat Exchange Catheter Kit with 3-lumen central venous infusion capabilities (REF 8700-0787-40, UDI: 00849111075220). This is a Class II recall involving all production lots of this device.
The FDA identified potential leaks from the catheter itself or from the start-up kit tubing. These leaks could occur during or after use of the device, potentially compromising its therapeutic function and patient safety. The manufacturer is addressing the issue through a labeling update.
The affected devices were distributed worldwide, including throughout the United States and internationally to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand. Medical facilities and hospitals that received this device may have affected units.
Healthcare providers should review the updated labeling and verify that any existing supply of this device matches the corrected information. Contact ZOLL Circulation for further guidance or to report any incidents related to this device.
The recalled product
- Product
- ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), STERILE EO, Rx Only, UDI: (01)00849111075220
- Manufacturer
- ZOLL Circulation, Inc.
- Hazard
- leakage
- medical-device-malfunction
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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