The Recall Desk
HighFDA (Devices)·Z-0056-2022·Announced 2021-10-13

Zoll ICY Intravascular Catheter Kit Recalled for Potential Tubing Leaks

ZOLL is recalling its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or tubing. An FDA labeling update has been issued to address this risk.

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 a risk-of-harm medical device (intravascular catheter) where potential leaks could affect device function and patient safety. No illnesses or injuries have been reported, and this is a Class II recall. Per the rubric, risk-of-harm products without reported injury score at most High (3).

Plain-English summary

ZOLL Circulation, Inc. is recalling the REF 8700-0695-40 (IC-3893AE) ICY Intravascular Heat Exchange Catheter Kit. The product is a sterile medical device designed for intravascular heat exchange with central venous infusion capabilities (three lumens).

The recall concerns potential leaks from the catheter or the start-up kit tubing. An FDA labeling update has been issued to address this potential risk.

The affected product has been distributed worldwide, including throughout the United States and internationally to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand. All manufacturing lots are included in this recall.

Healthcare facilities and individuals using this device should review the FDA labeling update regarding the potential leak risk.

The recalled product

Product
Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075077
Manufacturer
ZOLL Circulation, Inc.
Category
Medical Device — Intravascular Catheter
Hazard
Affected units
3

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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