FDAFDA · Food and drugs·Recall number Z-0056-2022
Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075077
Published October 13, 2021 · Recall initiated: August 6, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ZOLL Circulation, Inc.
- Distributor
- 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.
- Lot
- All Lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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