FDA-Device2014-12-03Class II

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

Beevers Manufacturing & Supply, Inc.
Hazard

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.

Sold states
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.
Affected count
16,575 units total (15,625 units in US and 950 units outside US)
Manufactured in
850 SW Booth Bend Rd, N/A, McMinnville, OR, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0483-2015

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