BEUDAMED
    FDA Recall Terminated

    MDI(R), S.A.L.T. Airway Device, Supraglottic Airway Laryngopharyngeal Tube, Intended for use with 6.5mm -9.00mm ET tubes, Including SALT(TM) airway, ET tube clamp, Latex-free securing strap, Tongue blade, Lubricating jelly, NON STERILE, REF 79-580, Microtek Medical, Inc., Columbus, MS 39702, www.microtekmed.com, Manufactured in the Dominican Republic of U.S. Materials Supraglottic Airway Laryngopharyngeal Tube which can be used to facilitate blind, endotracheal intubation.

    Recall: Z-1885-2011 · Initiated January 5, 2011

    Recall

    Recall Number
    Z-1885-2011
    Event Number
    57743
    Firm
    Microtek Medical Inc
    FEI Number
    1043582
    Product Code
    CAE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 5, 2011
    Terminated
    June 20, 2011
    Address
    602 N Lehmberg Rd, Columbus, MS, 39702-4406

    Description

    MDI(R), S.A.L.T. Airway Device, Supraglottic Airway Laryngopharyngeal Tube, Intended for use with 6.5mm -9.00mm ET tubes, Including SALT(TM) airway, ET tube clamp, Latex-free securing strap, Tongue blade, Lubricating jelly, NON STERILE, REF 79-580, Microtek Medical, Inc., Columbus, MS 39702, www.microtekmed.com, Manufactured in the Dominican Republic of U.S. Materials Supraglottic Airway Laryngopharyngeal Tube which can be used to facilitate blind, endotracheal intubation.

    Reason

    Product contains Triad Lubricating Jelly which was recalled.

    Action

    The firm, Microtek Medical, Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 17, 2011 to all consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and place any S.A.L.T. Airway Device (79-580) in quarantine; if they have distributed any of the product, they should identify their customers and notify them at once of this recall; complete and return the enclosed URGENT: MEDICAL DEVICE RECALL-RETURN RESPONSE form via fax to: (662)244-3011 or email: [email protected], and return any unused product inventory to Microtek Medical. The firm will provide the customers with a replacement product as soon as product becomes available. If you have any questions in regards to this recall, please feel free to contact the V.P.-Regulator Affairs at 1-888-844-0988 or email: [email protected].

    Distribution

    Nationwide distribution: AZ, CA, CT, FL, IN, MS, NC, NH, PA, TX and WI.

    Quantity

    223 cases of 10 units