BEUDAMED
    FDA Recall Terminated

    Jelco, Hypodermic needle Pro needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO.

    Recall: Z-2670-2017 · Initiated April 4, 2017

    Recall

    Recall Number
    Z-2670-2017
    Event Number
    77402
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    FMI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 4, 2017
    Terminated
    August 5, 2019
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    Jelco, Hypodermic needle Pro needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO.

    Reason

    Smiths Medical became aware on January 11, 2017, that syringe assemblies provided by Nipro Medical Corporation contained pin holes in the side wall of the hub. The defect was not detected during Smiths Medical incoming inspection. The syringe assemblies were used to manufacture seven (7) finished good lots of Hypodermic Needle Pro needles, Smiths Medical part numbers EL 1915 and SB5021.

    Action

    Smiths Medical sent an "Urgent Medical Device Recall Notice" dated April 04, 2017. The letter was addressed to Quality Assurance Manager & Associate Sourcing Consultant. The letter listed the Affected devices described the Reason for Recall, & Risk to Health. Requested consignee to complete Urgent Medical Device Recall Response Form within 10 days of receipt and send it to: [email protected]. For further questions, please call (603) 352-3812

    Distribution

    US Distribution to the state of : IN

    Quantity

    736,000