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ZOLL Circulation, Inc. recalls Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabiliti
Recalled October 13, 2021 · FDA recall Z-0047-2022 · ZOLL Circulation
Hazard
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing · FDA Class II
Units
33,066 units
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: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075251
Manufacturer(s)
ZOLL Circulation, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →