Z-0040-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 13, 2021
- Initiation Date
- August 6, 2021
- Termination Date
- October 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,253 Kits
Product Description
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
Reason for Recall
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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.
Code Information
All Lots