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.

Potential esophageal laceration during a patient procedure

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 Medical Device Recall Response Card included with this Customer Notification Letter. Your US Endoscopy Product Specialist can assist should you have any questions while completing the Card. 3. Return the completed Medical Device Recall Response Card via email to: [email protected] or via fax to 440-639-4495. If you have any questions regarding this matter, please call: 440-392-7633.