Reported May 17, 2017 · Terminated
Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment…
Mederi Therapeutics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mederi Therapeutics, Inc · 800 Connecticut Ave Ste 1E01 · Norwalk, CT · 06854-1628
Is this the product you have?
- 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
- Lot codes and dates
- Lot Numbers
291ST-16102ST-16102ST-16R-1102ST-16R-2116ST-16R116ST-16R2116ST-16R3116ST-16R4139ST-16139ST-16-1139ST-16-2139ST-16-3144ST-16209ST-16227ST-16243ST-16276ST-15286ST-16290ST-16291ST-16299ST-16306ST-16310ST-15
- Lot Numbers
- Amount recalled
- 1458 units
Where it was sold
- Nationwide
Why it was recalled
Product sterility compromised due to breach in sterile barrier package
This product could cause temporary or reversible health problems — stop using it.
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