Zoll ICY Intravascular Catheter Kit Recalled for Potential Tubing Leaks
ZOLL Circulation is recalling 3,425 units of the ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing. A labeling update has been issued.
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: FDA Class II recall with potential leaks in an intravascular catheter system. No reported illnesses or injuries have been documented, but the device is a high-risk medical product, and the potential for tubing leaks justifies a High severity rating per the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
ZOLL Circulation, Inc. is recalling the ICY Intravascular Heat Exchange Catheter Kit (Reference 8700-0782-03, Model IC-3893AE) due to potential leaks from the catheter or the start-up kit tubing. The device is a sterile, single-use medical device intended for intravascular heat exchange with central venous infusion capabilities. Approximately 3,425 units have been distributed worldwide.
The FDA has classified this as a Class II recall. The company is issuing a labeling update to inform healthcare providers of the potential leaks from the catheter or start-up kit tubing.
The device has been distributed worldwide, including throughout the United States and to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand. Healthcare facilities and clinicians should review the labeling update from ZOLL Circulation, Inc. for information about the potential leak risk and recommended actions.
The recalled product
- Product
- Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050180
- Manufacturer
- ZOLL Circulation, Inc.
- Hazard
- Affected units
- 3,425
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
Part of a larger recall action
This product is one of 28 recalled by ZOLL Circulation, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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