BEUDAMED
    FDA Recall Terminated

    Silicone Cuffed Wire Reinforced Extended Connect Pediatric Perfect Fit Neck Flange Tracheostomy Tube, Size 4.0 mm I.D. Catalog Number 353-040. Intended for use in providing direct tracheal access for airway management.

    Recall: Z-1628-2012 · Initiated April 18, 2012

    Recall

    Recall Number
    Z-1628-2012
    Event Number
    61663
    Firm
    Arcadia Medical Corporation
    FEI Number
    3004590970
    Product Code
    BTO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 18, 2012
    Posted
    May 21, 2012
    Terminated
    August 13, 2012
    Address
    1140 Millennium Dr, Crown Point, IN, 46307-7533

    Description

    Silicone Cuffed Wire Reinforced Extended Connect Pediatric Perfect Fit Neck Flange Tracheostomy Tube, Size 4.0 mm I.D. Catalog Number 353-040. Intended for use in providing direct tracheal access for airway management.

    Reason

    A defect in 3 tracheostomy tubes. The defect observed was a separation in the bond between the proximal junction of the neck flange and the cannula.

    Action

    Arcadia notified the 3 consignees with a MEDICAL DEVICE VOLUNTARY RECALL notification dated 4/18/12. The notification identified the affected product, along with the reason for the recall. Consignees were instructed to cease distribution/use of any unopened product that they have remaining and return to firm following the steps provided. Arcadia will replace the product at no charge to the customer. Consignees were to confirm receipt of the recall notification by emailing Trena Depel, [email protected]. Phone: 925-918-0595 Fax: (415) 762-5489

    Distribution

    Worldwide Distribution - US, including Mariemount, OH and countries of UK and France.

    Quantity

    01103307 (50 units) and 01107055 (73 units)