The Recall Desk
HighFDA (Devices)·Z-0045-2022·Announced 2021-10-13

ZOLL COOL LINE Catheter Kit recalled for potential tubing leaks

ZOLL has recalled its COOL LINE Intravascular Heat Exchange Catheter Kit due to potential leaks in catheter and tubing components, affecting approximately 6,395 units distributed worldwide.

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 of a critical medical device with a theoretical hazard (potential leaks in intravascular catheter components). Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3). No illnesses or injuries are mentioned in the source.

Plain-English summary

ZOLL Circulation, Inc. is recalling the COOL LINE Intravascular Heat Exchange Catheter Kit (REF 8700-0781-40, UDI 00849111075213). This sterile, heparin-coated medical device is designed for intravascular temperature control with central venous infusion capabilities and three lumens.

The recall was initiated due to a labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing.

Approximately 6,395 units were affected under all lot numbers. Distribution was worldwide, including throughout the United States and to countries including Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand.

The recalled product

Product
ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens) HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075213
Manufacturer
ZOLL Circulation, Inc.
Category
Medical Device — Intravascular Catheter
Hazard
Affected units
6,395

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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