BEUDAMED
    FDA Recall Open, Classified

    PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.

    Recall: Z-1363-2022 · Initiated May 20, 2022

    Recall

    Recall Number
    Z-1363-2022
    Event Number
    90253
    Firm
    Cordis US Corp
    FEI Number
    1016427
    Product Code
    FGE
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    May 20, 2022
    Address
    14201 Nw 60th Ave, Miami Lakes, FL, 33014-2802

    Description

    PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.

    Reason

    Potential for stent dislodgement and associated failures related to two specific sizes of the device.

    Action

    The recalling firm issued letters dated 5/16/2022 on 5/20/2022 via FedEx to the U.S. customers. The letter explained the issue, provided details on the affected device to assist in the identification of the product involved, and requested the consignee immediately check their inventory for the affected product and quarantine it. An Acknowledgment Form was enclosed for completion and return to the recalling firm. The consignee was to share the letter with others in their facility who need to be made aware of the recall and with any other facility that may have been sent the affected units.

    Distribution

    US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WY. There was also government/military distribution.

    Quantity

    1,089 units