FDA Enforcement
Class II
Terminated
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.
Recall: Z-1011-2019
·
Reported March 20, 2019
Enforcement
- Recall Number
- Z-1011-2019
- Event ID
- 82142
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- US Endoscopy Group Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 20, 2019
- Initiation Date
- February 4, 2019
- Classification Date
- March 13, 2019
- Termination Date
- August 3, 2020
- Address
- 5976 Heisley Rd, N/A, Mentor, OH, 44060-1873, United States
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
Potential esophageal laceration during a patient procedure
Code Info
Lot Numbers: 1814568, 1814569, 1815200, 1815592, 1816056, 1817174, 1817810, 1818187, 1818596, 1819180, 1819181, 1819407, 1819793, and 1820177.
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.
Quantity
483 units ( 325 units US and 158 OUS)