BEUDAMED
    FDA Recall Terminated

    Laceration Tray, Catalog # 1892R1 Product Usage: Surgical procedure

    Recall: Z-0544-2018 · Initiated June 27, 2017

    Recall

    Recall Number
    Z-0544-2018
    Event Number
    78950
    Firm
    Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
    FEI Number
    2433012
    Product Code
    PWY
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 27, 2017
    Terminated
    July 27, 2020
    Address
    75 Arkay Dr, Hauppauge, NY, 11788-3707

    Description

    Laceration Tray, Catalog # 1892R1 Product Usage: Surgical procedure

    Reason

    BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.

    Action

    On June 27, 2017, Busse Hospital Disposables distributed Urgent Medical Device Recall notices and Response Forms to their customers via courier service. A copy of the supplier's recall notice was also provided to customers. Customers were advised to conduct the following: " Discontinue use of needle immediately. " Please check your inventory and cease distribution immediately. " If you have distributed the above products, please contact your customers and inform them of this recall immediately. " Contact Busse Hospital Disposables for a Return Good Authorization number. " Complete and Return the Response Form via fax to 631-435-2849 or via email to: [email protected]. Customers with questions may call 631-435-4711, ext. 254.

    Distribution

    US Nationwide Distribution

    Quantity

    75 cases