The Recall Desk
HighFDA (Devices)·Z-0054-2022·Announced 2021-10-13

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.

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 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.
Category
Medical Device — Intravascular Catheter
Hazard
  • leak
  • 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.

Related recalls

Same category