ZOLL Circulation, Inc. recalls ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabiliti

Recalled October 13, 2021 · FDA recall Z-0046-2022 · ZOLL Circulation

Hazard

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing · FDA Class II

Units

333 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 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), STERILE EO, Rx Only, UDI: (01)00849111075220

Manufacturer(s)

ZOLL Circulation, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →