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ZOLL Circulation, Inc. recalls Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin, Sterile
Recalled October 13, 2021 · FDA recall Z-0048-2022 · ZOLL Circulation
Hazard
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing · FDA Class II
Units
20,475 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: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin, Sterile EO, Rx Only, UDI: (01)00849111075282
Manufacturer(s)
ZOLL Circulation, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →