The Recall Desk
HighFDA (Devices)·Z-0044-2022·Announced 2021-10-13

ZOLL COOL LINE Intravascular Catheter Kit Recalled for Potential Leaks

ZOLL Circulation is recalling COOL LINE intravascular heat exchange catheters due to potential leaks in the catheter or start-up kit tubing that could affect their function during medical procedures.

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 of a critical medical device (intravascular catheter) with potential for functional defect (leaks in catheter or tubing). No illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed, making this a risk-of-harm product without reported injury.

Plain-English summary

ZOLL Circulation, Inc. is recalling COOL LINE intravascular heat exchange catheter kits (REF 8700-0781-14, CL-2295CO) featuring three lumens and heparin coating. The recall involves 11 units that have been distributed worldwide, including throughout the United States and internationally to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand. All lots are included in this recall.

The recall has been issued due to a labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing. These potential leaks could affect the proper function of the device during medical procedures.

Healthcare providers and facilities that have received affected units should contact ZOLL Circulation, Inc. for instructions regarding this labeling update. Affected devices should not be used until updated labeling information and guidance from the manufacturer have been received.

The recalled product

Product
ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075510
Manufacturer
ZOLL Circulation, Inc.
Category
Medical Device
Hazard
Affected units
11

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.

The notice also names 37 states specifically:

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.

See all 28 products in this recall →

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