Recall Z-1011-2019— US Endoscopy Group Inc

Name: FDA recall Z-1011-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-04

Class II · Terminated

Class II FDA medical device recall by US Endoscopy Group Inc, initiated 2019-02-04, terminated 2020-08-03. It names one FDA 510(k) clearance: K120814. 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: Potential esophageal laceration during a patient procedure.

Recalling firm: US Endoscopy Group Inc
Classification: Class II
Status: Terminated
Initiated: 2019-02-04
Terminated: 2020-08-03
Firm location: Mentor, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K120814 — PADLOCK CLIP-12Aponos Medical Corp.·cleared 2012-09-06

K-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

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.