Z-2050-2017 Class II Terminated
FDA device recall Z-2050-2017 was initiated by Mederi Therapeutics, Inc on April 3, 2017 and is designated Class II. Reason for recall: Product sterility compromised due to breach in sterile barrier package The recall status is terminated (terminated October 10, 2017). Affected quantity: 1458 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 17, 2017
- Initiation Date
- April 3, 2017
- Termination Date
- October 10, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1458 units
Product Description
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
Reason for Recall
Product sterility compromised due to breach in sterile barrier package
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.
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