US Endoscopy Group product recalled over laceration hazard

Recall date

February 4, 2019

Source

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

Official notice title

US Endoscopy Group Inc recalls US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in flexible endoscop…

Recall number

Z-1011-2019

FDA classification

Class II

Brand / firm

US Endoscopy Group Inc

Sold / distributed

Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Czech Republic, Germany, Great Britain, India, Italy, Lebanon, Mexico, Netherlands, Norway, Philippines, S. Korea, Spain, Sweden and United Arab Emirates.

Why it was recalled

Potential esophageal laceration during a patient procedure

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

What was recalled

US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.