Recall Z-2050-2017— Mederi Therapeutics, Inc
Class II · Terminated
Class II FDA medical device recall by Mederi Therapeutics, Inc, initiated 2017-04-03, terminated 2017-10-10. It names one FDA 510(k) clearance: K152317. 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. Reason: Product sterility compromised due to breach in sterile barrier package.
- Recalling firm
- Mederi Therapeutics, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-04-03
- Terminated
- 2017-10-10
- Firm location
- Norwalk, CT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.