Recall Z-1011-2019 ยท PKL Hemostatic Metal Clip For The Gi Tract
US Endoscopy Group Inc
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.
| Date | Feb 4, 2019 |
| Status | Terminated |
| Reason | Potential esophageal laceration during a patient procedure |
| Root cause | Device Design |
| Action | The firm, US Endoscopy issued a Recall Notification Letter entitled "URGENT VOLUNTARY RECALL NOTICE" and dated 2/1/19 on 2/4/19 to Customers who purchased affected lots of the Padlock Defect closure system. The Recall Notification Letter was sent to domestic Customers via FedEx with delivery confirmation receipt. Affected international distributors issued Recall Notification Letter via email. Letter identifies the product, problem, and actions to take. The customer were instructed to do the following: 1. Quarantine affected Padlock Clip defect closure systems (C910001 ). 2. Complete the Medi |
| Quantity | 483 units ( 325 units US and 158 OUS) |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120814 | PADLOCK CLIP-12 Aponos Medical Corp., Sep 6, 2012 |