Zoll ICY Intravascular Catheter Kit: Labeling Update on Potential Leaks
ZOLL is updating labeling for ICY Intravascular Heat Exchange Catheter Kits due to potential leaks in the catheter or tubing. Healthcare providers should review updated guidance from the manufacturer.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is described as 'potential' and is being addressed through a 'labeling update,' consistent with a precautionary measure rather than a manifested critical defect.
Plain-English summary
ZOLL Circulation, Inc. is updating the labeling for ICY Intravascular Heat Exchange Catheter Kits (REF: 8700-0782-01) to address potential leaks from the catheter or start-up kit tubing.
The update affects approximately 17,869 kits distributed worldwide, including throughout the US and internationally to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand. All production lots are affected.
Healthcare providers should review the updated labeling from the manufacturer. For specific guidance and instructions, contact ZOLL Circulation, Inc. directly.
The recalled product
- Product
- Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens) , Femoral vein Insertion Only, Sterile EO, Rx Only, UDI: (01)00849111075237
- Manufacturer
- ZOLL Circulation, Inc.
- Hazard
- Affected units
- 17,869
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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