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ZOLL Circulation, Inc. recalls Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.)
Recalled October 13, 2021 · FDA recall Z-0060-2022 · ZOLL Circulation
Hazard
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing · FDA Class II
Units
42 bundles
Sold at
Worldwide distribution - US Nationwide distribution in the states of 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 the countries Australia, CANADA, CHINA, GERMANY, HUNGARY, PORTUGAL, SINGAPORE, TAIWAN, THAILAND.
Description
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Product
Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.)
Manufacturer(s)
ZOLL Circulation, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →