Z-1011-2019 Class II Terminated
FDA device recall Z-1011-2019 was initiated by US Endoscopy Group Inc on February 4, 2019 and is designated Class II. Reason for recall: Potential esophageal laceration during a patient procedure The recall status is terminated (terminated August 3, 2020). Affected quantity: 483 units ( 325 units US and 158 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- March 20, 2019
- Initiation Date
- February 4, 2019
- Termination Date
- August 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 483 units ( 325 units US and 158 OUS)
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
Distribution Pattern
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.
Code Information
Lot Numbers: 1814568, 1814569, 1815200, 1815592, 1816056, 1817174, 1817810, 1818187, 1818596, 1819180, 1819181, 1819407, 1819793, and 1820177.