BEUDAMED
    FDA Recall Terminated

    Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant. Product is used to lubricate vulvar and vaginal tissues to facilitate entry of diagnostic or therapeutic devices. Pre' Lubricant is acceptable for use to facilitate insertion of diagnostic or therapeutic devices during fertility interventions such as: embryo transfer, transvaginal collection of oocytes, intrauterine insemination and post coital testing. In addition, product may be used as a personal lubricant to supplement the body's own natural lubricating fluids.

    Recall: Z-0626-2009 · Initiated September 22, 2008

    Recall

    Recall Number
    Z-0626-2009
    Event Number
    49591
    Firm
    INGfertility, LLC
    FEI Number
    3006029862
    Product Code
    NUC
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    September 22, 2008
    Posted
    January 23, 2009
    Terminated
    May 2, 2012
    Address
    17206 S Spangle Creek Rd, Valleyford, WA, 99036-9569

    Description

    Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant. Product is used to lubricate vulvar and vaginal tissues to facilitate entry of diagnostic or therapeutic devices. Pre' Lubricant is acceptable for use to facilitate insertion of diagnostic or therapeutic devices during fertility interventions such as: embryo transfer, transvaginal collection of oocytes, intrauterine insemination and post coital testing. In addition, product may be used as a personal lubricant to supplement the body's own natural lubricating fluids.

    Reason

    Product contaminated with bacteria (Brachybacterium rhamnosum, a non pathogen gram positive cocci).

    Action

    Firm telephoned all wholesale, clinic, and retail customers on 9/22/08 requesting that product be returned.

    Distribution

    Worldwide Distribution including USA and country of Ireland.

    Quantity

    Unknown***