BEUDAMED
    FDA Recall Terminated

    Bausch & Lomb, Renu Fresh Multi-purpose Solution, 2 fl oz (60 mL), Travel Kit, Manufactured by: Bausch & Lomb Place, Rochester, NY 14609 Daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses.

    Recall: Z-1025-2011 · Initiated December 22, 2010

    Recall

    Recall Number
    Z-1025-2011
    Event Number
    57555
    Firm
    Bausch & Lomb Inc
    FEI Number
    1317628
    Product Code
    LYL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 22, 2010
    Posted
    February 2, 2011
    Terminated
    September 4, 2012
    Address
    1400 North Goodman Street, Rochester, NY, 14609-3547

    Description

    Bausch & Lomb, Renu Fresh Multi-purpose Solution, 2 fl oz (60 mL), Travel Kit, Manufactured by: Bausch & Lomb Place, Rochester, NY 14609 Daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses.

    Reason

    There is a potential for some packages to not meet sterility requirements.

    Action

    On December 8, 2010, Target was visited by FDA/PHI-DO and was informed on the violation. The Target customers that received lot GH0078 were requested to return all affected product directly to the Bausch & Lomb Greenville, SC Distribution Center. Bausch and Lomb sent an Urgent Voluntary Medical Device Recall to all first consignees who were shipped the affected lot GH0066 of Renu Fresh Multipurpose Solution on/about December 22, 2010. Since Target customers had already been notified previously regarding lot GH0078, this lot number was not included in the subsequent recall notification. All consignees were requested to review their inventory, and return any of the affected product to Stericycle Pharmaceutical Services, 2670 Executive Drive, Indianapolis, IN 46241. Stericycle is conducting this recall under the control of Bausch & Lomb. For questions abut the recall process contact Stericycle, Inc. at 1-888-345-8316. For questions regarding this recall call 1-800-828-6974.

    Distribution

    Worldwide Distribution - USA including AL, CA, CT, FL, GA, HI, IA, IN, LA, MA, MI, NE, NJ, NY, OH, PA, RI, SC, TN, TX, UT, VA, and WI and the countries Taiwan and Brazil

    Quantity

    146,496/ 2 oz Bottles