BEUDAMED
    FDA Recall 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 · Initiated February 4, 2019

    Recall

    Recall Number
    Z-1011-2019
    Event Number
    82142
    Firm
    US Endoscopy Group Inc
    FEI Number
    1000122656
    Product Code
    PKL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 4, 2019
    Terminated
    August 3, 2020
    Address
    5976 Heisley Rd, Mentor, OH, 44060-1873

    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

    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 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.

    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)