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Recall Observatory FDA recall evidence

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

April 03, 2017

Class II

Product summary

Firm
Mederi Therapeutics, Inc
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

    reason.sterility_assurance · v1.0.0

    sterility compromised