Recall Z-0064-2022 · NCX System, Hypothermia, Intravenous, Cooling

ZOLL Circulation, Inc.

Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer

Date	Aug 6, 2021
Status	Terminated
Reason	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Root cause	Labeling design
Action	Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected
Quantity	1,122 bundled kits
Distribution	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, T
FDA record	Open on fda.gov

510(k) clearances named in this recall

K150046

Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro In
Zoll Circulation, Inc., Oct 30, 2015