Device 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
Z-2050-2017
Product summary
- Event
- Event 76972
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1458 units
- Official record key
device-enforcement:Z-2050-2017
Official wording
Reason: Product sterility compromised due to breach in sterile barrier package
Code information: Lot Numbers: 291ST-16 102ST-16 102ST-16R-1 102ST-16R-2 116ST-16R 116ST-16R2 116ST-16R3 116ST-16R4 139ST-16 139ST-16-1 139ST-16-2 139ST-16-3 144ST-16 209ST-16 227ST-16 243ST-16 276ST-15 286ST-16 290ST-16 291ST-16 299ST-16 306ST-16 310ST-15
Distribution pattern: 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.
Derived failure modes
-
Sterility assurance
sterility compromised