FDA recall Z-1011-2019

Product

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.

Reason for recall

Potential esophageal laceration during a patient procedure

Distribution

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.

Key facts

Status

Terminated

Initiation date

2019-02-04

Report date

2019-03-20

Termination date

2020-08-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mentor, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1011-2019