BEUDAMED
    FDA Recall Terminated

    Vacuum Collection Bottle, 1/2 gallon (1300 mL); Ohio Medical Company, Gurnee, IL 60031; part number 0212-0301-600 (6700-0206-500); the bottles are sold alone and with various cap & float assemblies including: 0321-7986-801 - Bottle with Straight Wall Bracket, Cap & Float; 6700-0019-800 - Bottle with Floor Bracket, Cap & Float; 6700-0024-800 - Bottle with V Wall Bracket, Cap & Float. The collection bottles are part of a suction bottle assembly which is designed to collect various body fluids.

    Recall: Z-0089-2010 · Initiated September 21, 2009

    Recall

    Recall Number
    Z-0089-2010
    Event Number
    53192
    Firm
    Ohio Medical Corporation
    FEI Number
    1419185
    Product Code
    KDQ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 21, 2009
    Posted
    October 29, 2009
    Terminated
    June 22, 2011
    Address
    1111 Lakeside Dr, Gurnee, IL, 60031

    Description

    Vacuum Collection Bottle, 1/2 gallon (1300 mL); Ohio Medical Company, Gurnee, IL 60031; part number 0212-0301-600 (6700-0206-500); the bottles are sold alone and with various cap & float assemblies including: 0321-7986-801 - Bottle with Straight Wall Bracket, Cap & Float; 6700-0019-800 - Bottle with Floor Bracket, Cap & Float; 6700-0024-800 - Bottle with V Wall Bracket, Cap & Float. The collection bottles are part of a suction bottle assembly which is designed to collect various body fluids.

    Reason

    The re-useable collection bottles were made with polycarbonate instead of the specified polysulfone. The recommended cleaning of the bottles include use of ammonia and autoclaving, which may have an adverse impact on polycarbonate.

    Action

    Ohio Medical Corporation issued recall letters beginning September 17, 2009. Consignees were informed of the affected product and requested to return affected collection bottles to the firm. The accounts were requested to complete and return the enclosed acknowledgement form, indicating the number of affected units on hand, to obtain a returned material authorization for the return of the recalled bottles and their replacement. For further information, contact Ohio Medical Quality Assurance Manager, Anita Christ, at 847-855-6270.

    Distribution

    Worldwide Distribution -- United States, Canada, Chile, Costa Rica, Cyprus, Egypt, El Salvador, Greece, Hong Kong, India, Israel, Japan, Jordan, Korea, Kuwait, Malaysia, Netherlands, Oman, Paraguay, Philippines, Qatar, Saudi Arabia, Singapore, Thailand, Turkey, United Kingdom and Venezuela.

    Quantity

    5,892 bottles