FDA-Device2017-05-17Class II
Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease (GERD). REF 175-5580
Mederi Therapeutics, Inc
Hazard
Product sterility compromised due to breach in sterile barrier package
Sold states
Worldwide Distribution - Nationwide Distribution and to the countries of: Turkey, Great Britain, Belgium, Kuwait, Poland, Italy, India, China, Costa Rica, Australia, Malaysia, Jordan and Egypt.
Affected count
1458 units
Manufactured in
800 Connecticut Ave Ste 1E01, N/A, Norwalk, CT, United States
Products
Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease (GERD). REF 175-5580
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2050-2017Don't want to check this manually?
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