The Recall Desk
HighFDA (Devices)·Z-0060-2022·Announced 2021-10-13

Zoll ICY IV Disposable Pack Recall: Potential Catheter and Tubing Leaks

ZOLL Circulation recalls the ICY IV Disposable Pack and Start UP Kit due to potential leaks in the catheter or start-up kit tubing. The recall affects 42 bundles 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: Class II medical device recall with no reported injuries or illnesses. Potential leaks in IV medical device tubing represent a risk-of-harm to patients during medical care, even without evidence of harm yet reported. Per the rubric, risk-of-harm products where injury has not yet been reported score at most 3.

Plain-English summary

ZOLL Circulation, Inc. has recalled the Zoll REF 8700-000866-01 ICY IV™ Disposable Pack and Start UP Kit (6 ft.) due to potential leaks from the catheter or the start-up kit tubing. The recalled product consists of 42 bundles.

The potential for leaks in the catheter or start-up kit tubing could compromise the proper function of the ICY IV system. This device is used in emergency and medical care settings for therapeutic purposes.

The affected product was distributed worldwide, including throughout the United States in the following states: AL, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, and internationally to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand. All lots of the product are subject to recall.

The recalled product

Product
Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.)
Manufacturer
ZOLL Circulation, Inc.
Category
Medical Device — Intravenous Cooling Therapy
Hazard
Affected units
42

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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Same manufacturer · ZOLL Circulation, Inc.

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