Recall Z-2050-2017 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Mederi Therapeutics, Inc
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
| Date | Apr 3, 2017 |
| Status | Terminated |
| Reason | Product sterility compromised due to breach in sterile barrier package |
| Root cause | Package design/selection |
| Action | Mederi issued initial recall on March 29, 2017, and on April 3, 2017, with a corrected recall letter requesting users identify product and set aside for an inspection by Mederi personnel. Once the inspection is completed return the Acknowledgement Form Customer Service, return via eFax at 888-215-9883, or email to customerservice@mederi-inc.com. Mederi will provide FedEx labels and ensure appropriate packaging for the return. For further questions, please call (203) 930-9900. |
| Quantity | 1458 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152317 | Stretta Catheter Mederi Therapeutics, Inc., Sep 23, 2015 |