BEUDAMED
    FDA Recall Terminated

    Hemospray Endoscopic Hemostat

    Recall: Z-2541-2019 · Initiated July 24, 2019

    Recall

    Recall Number
    Z-2541-2019
    Event Number
    83395
    Firm
    Wilson-Cook Medical Inc.
    FEI Number
    1037905
    Product Code
    QAU
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 24, 2019
    Terminated
    June 15, 2020
    Address
    4900 Bethania Station Rd, Winston Salem, NC, 27105-1203

    Description

    Hemospray Endoscopic Hemostat

    Reason

    Potential for Hemospray device to be unable to spray powder due to misassembly of devices.

    Action

    Cook Medical notified customers starting on about 07/24/2019 via "URGENT: MEDICAL DEVICE RECALL" letter. Customers were informed that complaints have been received by Cook Medical that the Hemospray device is potentially unable to spray powder due to misassembly of the device. The potential risk involved includes delayed hemostasis, the need for additionaly hemostasis, and/or the patient may need to be transferred to surgery. If Hemostasis cannot be achieved in a timely manner in emergent cases, this may result in death. Instructions to customers include to immediately review the labels of impacted in inventory and quarantine any affected product that remains unused. All affected product on hand should be returned to Cook Medical and include the completed Acknowledgement and Receipt Form. The response form should be returned via fax (812.339.7316) or email [email protected]. If the customer is a distributor, and the products have been further distributed, contact all customers and direct them to quarantine any affected product. For questions, please contact the Customer Relations Department at Cook Medical for more information or if you have questions. Please use [email protected], or call toll free 1-800-457-4500, press 4, then enter extension 15-2146, Monday through Friday, 8:00AM to 4:30PM, Eastern Time.

    Distribution

    Nationwide distribution to CA, CO, CT, FL, IL, IN, KY, LA, MN, MO, NC, NJ, NY, OH, PA, RI, SD, TX, VA, WA. International distribution to Canada, Austria, Belgium, Cyprus, Denmark, France, Germany, Greece, Italy, Portugal, Spain, and United Kingdom.

    Quantity

    160 units