BEUDAMED
    FDA Recall Terminated

    Tracheostomy Tubes, Jackson Improved Stainless Steel with Adapter, item number 8100465 size 1, item number 8100373 size 3, item number 1034924 size 4, item number 1034925 size5, item number 1034926 size 6, item number 1034927 size 7, item number 1034928 size 8, item number 8100468 size 9, and item number 8100234 size 10.

    Recall: Z-1461-04 · Initiated August 5, 2004

    Recall

    Recall Number
    Z-1461-04
    Event Number
    29920
    Firm
    Premier Dental Products Co
    FEI Number
    2511556
    Product Code
    JOH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 5, 2004
    Posted
    September 15, 2004
    Terminated
    November 23, 2005
    Address
    1710 Romano Dr, Plymouth Meeting, PA, 19462-2822

    Description

    Tracheostomy Tubes, Jackson Improved Stainless Steel with Adapter, item number 8100465 size 1, item number 8100373 size 3, item number 1034924 size 4, item number 1034925 size5, item number 1034926 size 6, item number 1034927 size 7, item number 1034928 size 8, item number 8100468 size 9, and item number 8100234 size 10.

    Reason

    foreign objects (polishing stones) in the tubes

    Action

    The recalling firm issued a recall letter dated 8/5/04 to their distributors. The letter informs the accounts of the problem and the need to return any affected product. The recalling firm issued a second letter dated 8/11/04 to the distributors with instructions to conduct a sub-recall.

    Distribution

    The products were shipped to 45 distributors nationwide. The products were also shipped to Canada, Malaysia, Taiwan, Thailand, Turkey, and the Dominican Republic.

    Quantity

    22,324 tubes