Home / Recalls / Medical Devices
Mederi Therapeutics, Inc recalls Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatmen
Recalled May 17, 2017 · FDA recall Z-2050-2017 · Mederi Therapeutics
Hazard
Product sterility compromised due to breach in sterile barrier package · FDA Class II
Units
1458 units
Sold at
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.
Description
Product sterility compromised due to breach in sterile barrier package
Product
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
Manufacturer(s)
Mederi Therapeutics, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →