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Terminated

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

FDA Recall Z-2050-2017 · Posted None

Recalling FirmMederi Therapeutics, Inc
Recall StatusTerminated
Product CodeGEI
Date Initiated2017-04-03
Date Terminated2017-10-10
Product Quantity1458 units

Reason for Recall

Product sterility compromised due to breach in sterile barrier package

Firm 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 [email protected]. Mederi will provide FedEx labels and ensure appropriate packaging for the return. For further questions, please call (203) 930-9900.

Root Cause

Package design/selection

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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