BEUDAMED
    FDA Recall Terminated

    Silicone CTS (Close to Shaft) Cuff Adjustable Neck Flange Tracheostomy Tube (Wire Reinforced), Arcadia Medical Silicone Air Cuff Adjustable Tracheostomy Tube, Sterile, Latex-Free, Provides direct tracheal access for airway management Arcadia Medical Corporation 1450 East American Lane, Schaumburg, IL 60173 USA Arcadia Medical Corporation Tortola, British Virgin Islands www.arcadiamedical.com, Made in USA

    Recall: Z-2657-2011 · Initiated May 8, 2011

    Recall

    Recall Number
    Z-2657-2011
    Event Number
    58828
    Firm
    Arcadia Medical Corporation
    FEI Number
    3004590970
    Product Code
    BTO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 8, 2011
    Posted
    June 24, 2011
    Terminated
    August 30, 2011
    Address
    1140 Millennium Dr, Crown Point, IN, 46307-7533

    Description

    Silicone CTS (Close to Shaft) Cuff Adjustable Neck Flange Tracheostomy Tube (Wire Reinforced), Arcadia Medical Silicone Air Cuff Adjustable Tracheostomy Tube, Sterile, Latex-Free, Provides direct tracheal access for airway management Arcadia Medical Corporation 1450 East American Lane, Schaumburg, IL 60173 USA Arcadia Medical Corporation Tortola, British Virgin Islands www.arcadiamedical.com, Made in USA

    Reason

    The product does not contain a punched hole above the cuff access port (a lumen that enables suctioning of secretions proximal to the inflated cuff) as intended by the devices design. This eliminates the user's ability to suction secretions through this suction port, necessitating that the user revert to standard of care methods for suctioning secretions from around the cuffed trach tube shaft.

    Action

    Arcadia Medical Corporation sent a "MEDICAL DEVICE RECALL" letter on May 9, 2011 and email on May 8, 2011 to all affected costumers. The letter included; description of the product name, afffected lot numbers, description of the problem, instructions to discontinue use of the recalled devices and to return them to Arcadia Medical for replacement . The letter instructed the customers to email Arcadia Medical with the number of devices in their inventory. For additional information contact Arcadia Medical Corporation at 219-779-9431.

    Distribution

    Worldwide Distribution --USA including the state of Ohio, and the countries of Denmark, Italy, Germany, Turkey, Slovakia, Isreal, France, Sweden, and Romania

    Quantity

    118