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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- 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
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.
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