BEUDAMED
    FDA Enforcement Class II Terminated

    Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a) 650704100 551310 (b) 650704120 551312 (c) 650704160 551316 Product Usage: RUSCH Simplastic Suprapubic Puncture Instruments are indicated for emergency suprapubic drainage of the bladder.

    Recall: Z-1369-2018 · Reported April 18, 2018

    Enforcement

    Recall Number
    Z-1369-2018
    Event ID
    79579
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical Europe Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    April 18, 2018
    Initiation Date
    March 15, 2018
    Classification Date
    July 5, 2018
    Termination Date
    October 5, 2020
    Address
    Ida Business Park, Athlone, N/A, Ireland

    Description

    Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a) 650704100 551310 (b) 650704120 551312 (c) 650704160 551316 Product Usage: RUSCH Simplastic Suprapubic Puncture Instruments are indicated for emergency suprapubic drainage of the bladder.

    Reason

    These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.

    Code Info

    Product Code Equivalent Code (a) 650704100 551310 Batch Numbers: 13HE35 14KE45 (b) 650704120 551312 Batch Numbers: 13EE20 13HE35 13JE43 14AE02 14BE07 14EE21 14GE29 14IE39 15AE03 15HE32 (c) 650704160 551316 Batch Numbers: 13GE31 13HE35 13JE41 13JE42 13JE43 13KE48 14AE03 14BE07 14CE11 14DE17 14DE18 14EE21 14EG21 14GE28 14HE33 14HE35 14IE39 14KE45 15AE03 15EE20 15EE22 15GE28 15JE43 15JE44 13EG28 13HG23

    Distribution

    US Nationwide Distribution

    Quantity

    4220 units