BEUDAMED
    FDA Recall 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 · Initiated December 20, 2013

    Recall

    Recall Number
    Z-0990-2014
    Event Number
    67154
    Firm
    Perrigo Diabetes Care
    FEI Number
    1811666
    Product Code
    FKB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 20, 2013
    Posted
    February 19, 2014
    Terminated
    August 5, 2014
    Address
    3780 Mansell Rd, Ste T50, Alpharetta, GA, 30022-1112

    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

    Action

    Perrigo Diabetes Care sent a recall notice dated December 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to segregate the affected productt and request return of all undistributed/unused sets from their customer warehouses to Omni Manufacturing Services S.A. de C.V., Parque Industrial Queretaro, La Noria Lt. 13. Mz 3 No. 125, Santo Rosa Jauregui, MX-76220 Santiago de Queretaro. Customers were instructed to distribute the attached "Urgent Field Safety Notice" to all users or patients who have been shipped any products from the affected lots. Customers with questions were instructed to call Perrigo Diabetes Care at 1-888-775-1997.

    Distribution

    Nationwide Distribution including GA & TX

    Quantity

    7924 units