ZOLL Circulation, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0041-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only, UDI: (01)00849111075190

Product Classification:

Class II

Date Initiated: August 6, 2021

Date Posted: October 13, 2021

Recall Number: Z-0041-2022

Event ID: 88671

Reason for Recall:

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

Status: Terminated

Product Quantity: 4,812 kits

Code Information:

All Lots

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated