ZOLL Circulation, Inc. recalls Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.)

Recalled October 13, 2021 · FDA recall Z-0059-2022 · ZOLL Circulation

Hazard

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

Units

55 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 8700-000865-01, Cool Line 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 →