Mederi Therapeutics, Inc recalls Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment…

Recall date

April 3, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2050-2017

FDA classification

Class II

Brand / firm

Mederi Therapeutics, Inc

Sold / distributed

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.

Why it was recalled

Product sterility compromised due to breach in sterile barrier package

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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