BEUDAMED
    FDA Recall Terminated

    Cannulaide, Model 101. The Cannulaide product is composed of die-cut hydrocolloid coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface. The Cannulaide is applied under and over the nose of infants to provide a protective barrier to the philtrum, columella, septum, nares, and tip of nose. It is available in multiple sizes that vary the external geometry and nare hole size and spacing to allow for use on infants ranging from less than 700 grams to greater than 3000 grams. It is a non sterile, single patient use, disposable device.

    Recall: Z-0487-2015 · Initiated January 18, 2007

    Recall

    Recall Number
    Z-0487-2015
    Event Number
    69648
    Firm
    Beevers Manufacturing & Supply, Inc.
    FEI Number
    3023468
    Product Code
    BZD
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    January 18, 2007
    Posted
    December 2, 2014
    Terminated
    December 1, 2014
    Address
    850 SW Booth Bend Rd, McMinnville, OR, 97128-9320

    Description

    Cannulaide, Model 101. The Cannulaide product is composed of die-cut hydrocolloid coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface. The Cannulaide is applied under and over the nose of infants to provide a protective barrier to the philtrum, columella, septum, nares, and tip of nose. It is available in multiple sizes that vary the external geometry and nare hole size and spacing to allow for use on infants ranging from less than 700 grams to greater than 3000 grams. It is a non sterile, single patient use, disposable device.

    Reason

    Cannulaide model CA 101 was recalled because the firm discovered this model was packed and labeled as CA 102.

    Action

    Beevers Manufacturing and Supply, Inc. (BMS) of McMinnville, Oregon, began notifying consignees about this recall on 1/18/2007. Customers were advised to inspect blue box that say size 2 (CA 102) and check if size 1 (CA 101) was packed inside. Salter Labs provided BMS' recall report to FDA in October 2014.

    Distribution

    Worldwide Distribution: US (nationwide) and country of: ME-Musaffah.

    Quantity

    393 units