Home / Recalls / Mederi Therapeutics, Inc / Z-2050-2017

Z-2050-2017 Class II Terminated

Recalled by Mederi Therapeutics, Inc — Norwalk, CT

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