FDA-Device2021-10-13Class II
Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.)
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
16 bundles
Manufactured in
2000 Ringwood Ave, San Jose, CA, United States
Products
Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0058-2022Don't want to check this manually?
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