BEUDAMED
    FDA Recall Terminated

    SourceOne Healthcare Technologies brand, Ultrasound Tray, Cat. 255825R1, Lot 0503, Exp. 11-07, packaged as 10 trays per case.

    Recall: Z-1572-05 · Initiated January 18, 2005

    Recall

    Recall Number
    Z-1572-05
    Event Number
    33314
    Firm
    North Coast Medi-Tek Inc
    FEI Number
    1526414
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 18, 2005
    Posted
    September 21, 2005
    Terminated
    February 21, 2007
    Address
    8603 East Ave, Mentor, OH, 44060-4366

    Description

    SourceOne Healthcare Technologies brand, Ultrasound Tray, Cat. 255825R1, Lot 0503, Exp. 11-07, packaged as 10 trays per case.

    Reason

    Outside box labeling, containing 10 trays, incorrectly identified the product as ultrasound trays. Product is Breast Biopsy trays, Cat. 255826R2. Individual tray package labeling correctly identifies the product as Breast Biopsy tray.

    Action

    The recalling firm sent corrected labels to the distributor for the labeling of all 5 cases that were on hand.

    Distribution

    The product was distributed to one customer: Source One Healthcare Technologies distribution center, 4434 Mulhauser Road #300, Hamilton, OH 45011.

    Quantity

    5 cases, each case containing 10 kits (50 total kits).