Z-0039-2022 Class II Terminated
FDA device recall Z-0039-2022 was initiated by ZOLL Circulation, Inc. on August 6, 2021 and is designated Class II. Reason for recall: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing The recall status is terminated (terminated October 18, 2024). Affected quantity: 17,869 Kits.
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
- 17,869 Kits
Product Description
Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens) , Femoral vein Insertion Only, Sterile EO, Rx Only, UDI: (01)00849111075237
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