Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075251
Reported: October 13, 2021 Initiated: August 6, 2021 #Z-0047-2022
Product Description
Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075251
Reason for Recall
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Details
- Recalling Firm
- ZOLL Circulation, Inc.
- Units Affected
- 33,066 units
- Distribution
- 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.
- Location
- San Jose, CA
Frequently Asked Questions
What product was recalled? ▼
Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075251. Recalled by ZOLL Circulation, Inc.. Units affected: 33,066 units.
Why was this product recalled? ▼
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 13, 2021. Severity: Moderate. Recall number: Z-0047-2022.
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