Zoll COOLINE Intravascular Catheter Kit recalled for potential leak hazard
ZOLL Circulation is recalling the COOLINE Intravascular Heat Exchange Catheter Kit due to potential leaks from the catheter or start-up kit tubing. 2,833 units are affected globally.
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 3/5 (High).
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 recall for a high-risk medical device (intravascular catheter) where potential leaks could compromise patient safety. No illnesses or injuries have been reported, meeting the criteria for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
ZOLL Circulation, Inc. is recalling the COOLINE Intravascular Heat Exchange Catheter Kit (REF 8700-0781-03, CL-2295AE) due to potential leaks from the catheter or the start-up kit (SUK) tubing. A total of 2,833 units have been recalled.
The potential leak hazard could compromise the device's intended function for temperature management and patient safety during clinical use. The issue affects all lots of the product.
The affected product was distributed worldwide, including US nationwide distribution across all 50 states and territories, and internationally to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand.
Healthcare facilities and providers currently using this device should stop use and contact ZOLL Circulation, Inc. for guidance on device replacement or corrective measures. The FDA and manufacturer are coordinating on further communications regarding this recall.
The recalled product
- Product
- Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050173
- Manufacturer
- ZOLL Circulation, Inc.
- Hazard
- Affected units
- 2,833
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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