BEUDAMED
    FDA Enforcement Class II Terminated

    Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing; Single-Use Set Orbit Infusion Sets are sterile, non-pyrogenic, single-use devices intended to be used for subcutaneous delivery of medication , for example insulin, from an external infusion pump.

    Recall: Z-0990-2014 · Reported February 26, 2014

    Enforcement

    Recall Number
    Z-0990-2014
    Event ID
    67154
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Perrigo Diabetes Care
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 26, 2014
    Initiation Date
    December 20, 2013
    Classification Date
    February 19, 2014
    Termination Date
    August 5, 2014
    Address
    3780 Mansell Rd Ste T50, Alpharetta, GA, 30022-1112, United States

    Description

    Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing; Single-Use Set Orbit Infusion Sets are sterile, non-pyrogenic, single-use devices intended to be used for subcutaneous delivery of medication , for example insulin, from an external infusion pump.

    Reason

    Perrigo was notified by our supplier, Ypsomed AG, that they are recalling these batches due to being manufactured with a non-conforming female luer-lock connector. The luer-lock connectors are incompatible with standard male luer-lock connectors for use in connection to compatible infusion pumps. Perrigo became was notified of a quality complaint related to this issue on November 20, 2013 from a

    Code Info

    400064, 400069, 400070, & 400072 UPC: 7613117009502

    Distribution

    Nationwide Distribution including GA & TX

    Quantity

    7924 units