BEUDAMED
    FDA Enforcement Class II Terminated

    Cannulaide, Model 101, 102, 103. Respirator. 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-0483-2015 · Reported December 3, 2014

    Enforcement

    Recall Number
    Z-0483-2015
    Event ID
    69627
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beevers Manufacturing & Supply, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 3, 2014
    Initiation Date
    May 13, 2008
    Classification Date
    November 26, 2014
    Termination Date
    November 28, 2014
    Address
    850 SW Booth Bend Rd, N/A, McMinnville, OR, 97128-9320, United States

    Description

    Cannulaide, Model 101, 102, 103. Respirator. 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 recalled May 2008 due to improper seal of the pouch. The improper seal of the Cannulaide's package could potentially affect the device shelf life.

    Code Info

    CA 101: Lot 54219; CA 102: Lot 52834; CA 103: Lot 53813;

    Distribution

    Worldwide Distribution - US Distribution including the states of LA, GA, OR, MA, NJ, FL and CA., and the countries of Canada, France, Japan, Netherlands and United Kingdom.

    Quantity

    16,575 units total (15,625 units in US and 950 units outside US)