ZOLL Circulation, Inc. recalls Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with

Recalled October 13, 2021 · FDA recall Z-0040-2022 · ZOLL Circulation

Hazard

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

Units

1,253 Kits

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: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous infusion capabilities (3 lumens), Femoral Vein Insertion Only, Sterile EO, Rx only, UDI: (01)008491110 7550 3

Manufacturer(s)

ZOLL Circulation, Inc.

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