FDA-Device2021-10-13Class II
Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305
ZOLL Circulation, Inc.
Hazard
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Sold states
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.
Affected count
1,733 units
Manufactured in
2000 Ringwood Ave, San Jose, CA, United States
Products
Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0053-2022Don't want to check this manually?
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