Z-0043-2022 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
- 5, 345 KIts
Product Description
ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (00)849111075312
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