ClearanceBrief
Recall Z-0051-2022 ยท NCX System, Hypothermia, Intravenous, Cooling

ZOLL Circulation, Inc.

Zoll REF: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075534

DateAug 6, 2021
StatusTerminated
ReasonLabeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Root causeLabeling design
ActionBetween 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
Quantity188 units
DistributionWorldwide 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 recordOpen on fda.gov

510(k) clearances named in this recall

K150046Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro In
Zoll Circulation, Inc., Oct 30, 2015