The Recall Desk
HighFDA (Devices)·Z-0055-2022·Announced 2021-10-13

Zoll ICY Intravascular Catheter Kit Recalled for Potential Tubing Leaks

ZOLL Circulation is recalling 3,425 units of the ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing. A labeling update has been issued.

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 with potential leaks in an intravascular catheter system. No reported illnesses or injuries have been documented, but the device is a high-risk medical product, and the potential for tubing leaks justifies a High severity rating per the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

ZOLL Circulation, Inc. is recalling the ICY Intravascular Heat Exchange Catheter Kit (Reference 8700-0782-03, Model IC-3893AE) due to potential leaks from the catheter or the start-up kit tubing. The device is a sterile, single-use medical device intended for intravascular heat exchange with central venous infusion capabilities. Approximately 3,425 units have been distributed worldwide.

The FDA has classified this as a Class II recall. The company is issuing a labeling update to inform healthcare providers of the potential leaks from the catheter or start-up kit tubing.

The device has been distributed worldwide, including throughout the United States and to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand. Healthcare facilities and clinicians should review the labeling update from ZOLL Circulation, Inc. for information about the potential leak risk and recommended actions.

The recalled product

Product
Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050180
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

Same category