The Recall Desk
HighFDA (Devices)·Z-0041-2022·Announced 2021-10-13

ZOLL COOL LINE Intravascular Catheter Kit recalled for potential tubing leaks

ZOLL Circulation is recalling 4,812 COOL LINE Intravascular Heat Exchange Catheter Kits worldwide due to potential leaks in the catheter or startup kit tubing.

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 intravascular catheter with potential leak defect. Meets rubric criterion for risk-of-harm product where injury has not yet been reported. No hospitalization reports, so score is limited to 3.

Plain-English summary

ZOLL Circulation, Inc. is recalling the ZOLL COOL LINE Intravascular Heat Exchange Catheter Kit (Model 8700-0781-01 / CL-2295) due to potential leaks from the catheter or the startup kit (SUK) tubing.

The recall affects 4,812 kits distributed worldwide to healthcare facilities in all US states and internationally to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand.

As an FDA Class II recall, this issue has been identified through a labeling review. Further information and specific instructions regarding the recalled units should be obtained from ZOLL Circulation, Inc.

The recalled product

Product
ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only, UDI: (01)00849111075190
Manufacturer
ZOLL Circulation, Inc.
Category
Medical Device — Intravascular Catheter
Hazard
  • leak

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

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