BEUDAMED
    FDA Recall Terminated

    OASIS Medical SOFT PLUG Extended Duration Plug, Reference 6403 (Lot LA1105E)

    Recall: Z-1520-06 · Initiated July 6, 2006

    Recall

    Recall Number
    Z-1520-06
    Event Number
    36277
    Firm
    Oasis Medical Inc
    FEI Number
    2083373
    Product Code
    LZU
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    July 6, 2006
    Posted
    September 23, 2006
    Terminated
    September 1, 2011
    Address
    512 S Vermont Ave, Glendora, CA, 91741-6205

    Description

    OASIS Medical SOFT PLUG Extended Duration Plug, Reference 6403 (Lot LA1105E)

    Reason

    Labeled with an incorrect diameter

    Action

    OASIS Medical informed all customers via FAX and Certified Mailt that received the product that the firm was voluntarily recalling one lot of the SOFT PLUG Extended Duration Plugs (REF 6403) and to cease use immediately. Customers are advised to check their inventory and return any remaining and return all unused product to OASIS Medical SOFT PLUG Extended Duration Plugs (REF 6403) from Lot LA1105E by FedEx. Customers are also advised that if they have used the product, to inform OASIS Medical of the number of samples of this lot used for an accurate account of the product distributed, used and returned.

    Distribution

    Worldwide distribution ----USA and countries of Chile, and United Kingdom.

    Quantity

    1,212 SOFT PLUG¿ Extended Duration Plug pouches of Lot LA1105E. Each pouch contains 2 plugs.