BEUDAMED
    FDA Recall Terminated

    ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.

    Recall: Z-2109-2013 · Initiated August 19, 2013

    Recall

    Recall Number
    Z-2109-2013
    Event Number
    65886
    Firm
    Roche Diagnostics Operations, Inc.
    FEI Number
    1823260
    Product Code
    FMK
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    August 19, 2013
    Posted
    August 28, 2013
    Terminated
    May 12, 2014
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.

    Reason

    Internal Roche inspections have revealed that after the lancet is used for a finger stick, the needle may not fully retract back within the lancet drum or back into the cap. This allows the needle to protrude inside the cap or outside of the cap of the ACCU-CHEK FastClix lancing device.

    Action

    On 8/19/ 2013, Roche sent Distributor/Retailer URGENT MEDICAL DEVICE CORRECTION notifications which described the recall issue and health consequences, provided product description, and provided actions required of consignees. Roche sent a CUSTOMER BULLETIN to their direct customers. URGENT MEDICAL DEVICE CORRECTION faxback form for consignee acknowledgement of recall is to be faxed to 1-888-240-2804. Consignees may contact the ACCU-CHEK Customer Care Service Center, 24 hours a day, seven days a week at 1-800-440-3638 if they have questions about the information contained in the Distributor/Retailer Letter.

    Distribution

    Nationwide Distribution

    Quantity

    36,332