BEUDAMED
    FDA Recall Terminated

    DPOC-15, Cholangioscopy Access Balloon, G54951, 15 mm, Rx only, Cook Medical, Winston-Salem, NC 27105 This device is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. Also, used for endoscopic removal of biliary stones.

    Recall: Z-0925-2011 · Initiated December 23, 2010

    Recall

    Recall Number
    Z-0925-2011
    Event Number
    57573
    Firm
    Cook Endoscopy
    FEI Number
    1037905
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 23, 2010
    Posted
    January 19, 2011
    Terminated
    August 4, 2011
    Address
    5951 Grassy Creek Blvd, Winston Salem, NC, 27105-1206

    Description

    DPOC-15, Cholangioscopy Access Balloon, G54951, 15 mm, Rx only, Cook Medical, Winston-Salem, NC 27105 This device is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. Also, used for endoscopic removal of biliary stones.

    Reason

    Product defect; There is a risk of gastrointestinal perforation due to balloon deflation difficulty or air embolism resulting in poor patient outcomes including death.

    Action

    The firm, Cook Medical, sent an "URGENT: PRODUCT RECALL" letter dated January 7, 2011, to all customers. The letter described the product, problem and the actions to be taken by the customers. The customers were instructed to quarantine any affected product and return to Cook Medical. If they are distributors, they were instructed to contact their customers, direct them to quarantine any affected product and coordinate the return of the affected product to Cook Medical. The customers were also instructed to complete and return the bottom of the letter and send to Cook Medical as well as the PRODUCT RECALL EFFECTIVENESS SURVEY via fax at 812-339-7316 or scanned and emailed to [email protected]. Note: All non-responding customers will receive a total of three (3) recall notifications ( two (2) follow up requests for a response in addition to the initial recall notification). Should you have any questions, please contact the Customer Relations Department at Cook Medical for more information. Please use [email protected] or call toll free at 1-800-457-4500, press 4 then enter extension 2146.

    Distribution

    Worldwide distribution: USA including states of: AL, CA, FL, IL, IN, LA, MA, NC, NY, OH, PA, SC, TN, TX, WA, and WI; and countries of: Belgium, Canada, Germany, Hong Kong, and the Netherlands..

    Quantity

    103 units (total for both units under recall)