BEUDAMED
    FDA Recall Terminated

    Other-Sonic Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.

    Recall: Z-1653-2012 · Initiated March 2, 2012

    Recall

    Recall Number
    Z-1653-2012
    Event Number
    61732
    Firm
    Pharmaceutical Innovations, Inc.
    FEI Number
    2241583
    Product Code
    MUI
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    March 2, 2012
    Posted
    May 24, 2012
    Terminated
    July 19, 2021
    Address
    897 Frelinghuysen Ave, Newark, NJ, 07114-2122

    Description

    Other-Sonic Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.

    Reason

    Other-Sonic GENERIC ULTRASOUND TRANSMISSION GEL is being recalled due to possible microbial contamination. An FDA Safety Communication was issued for this product on April 18, 2012.

    Action

    Phamaceutical Innovations Inc. sent an Urgent Message Notice letter dated March 02, 2012 with a followup letter dated March 9, 2012 and an Inventory Withdrawal letter dated March 23, 2012 via email and fax to all affected customers. Customers were instructed to examinne inventory, refrain from distribution and return remaining inventory for a replacement. For questions call 973-242-2900.

    Distribution

    Worldwide Distribution - United States (nationwide) including the states of: FL, MA, MS, NJ, OH, TN and VA, and the countries of: Canada and Australia.

    Quantity

    40,164 units in distribution worldwide - unable to obtain units in distribution Nationwide