BEUDAMED
    FDA Recall Terminated

    DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remove organs or tissue from the body cavity.

    Recall: Z-1642-2015 · Initiated April 17, 2015

    Recall

    Recall Number
    Z-1642-2015
    Event Number
    71193
    Firm
    DeRoyal Industries Inc
    FEI Number
    1043214
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 17, 2015
    Posted
    May 21, 2015
    Terminated
    December 29, 2015
    Address
    200 Debusk Ln, Powell, TN, 37849-4703

    Description

    DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remove organs or tissue from the body cavity.

    Reason

    The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use.

    Action

    DeRoyal sent an Urgent: Voluntary Recall letter dated April 17, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to 1. Check your inventory for the product and specific lot number from the attached Recall Response Form. 2. If you have affected inventory, please destroy it and dispose of it according to your facilitys procedures. 3. Record all information on the included Recall Response and Notice of Destruction forms. 4. If you purchase through a distributor, please indicate their name/location on the Notice of Destruction Form so that we may issue credit appropriately. 5. Return both forms to [email protected] or 865-362-3716 (fax) even if you no longer have affected inventory. 6. Once we have received your Recall Response and Notice of Destruction forms, you will receive credit for destroyed product as indicated on the form. 7. If you are a distributor of these products, please forward this recall notice on to your end-users, or provide us with your customer listing and we will gladly contact them for you. For questions regarding this recall, please contact your DeRoyal Sales Representative or DeRoyal Customer Service at 1-800-251-9864.

    Distribution

    US Nationwide Distribution

    Quantity

    5359 units