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.
FDA Recall Z-0483-2015 · Posted 2014-12-01
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Recalling FirmBeevers Manufacturing & Supply, Inc.
Recall StatusTerminated
Product CodeBZD
Date Initiated2008-05-13
Date Terminated2014-11-28
Product Quantity16,575 units total (15,625 units in US and 950 units outside US)
Reason for Recall
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.
Firm Action
Beevers Manufacturing & Supply, Inc. (BMS) did contact the customers via letter and phone call in May 2008. Customers that didn't reply were further contacted via email on June 2008.
Salter Labs provided BMS' recall report to FDA in October 2014.
Salter Labs was unable to locate a recall letter issued by BMS to the affected customers. For further questions please call (503) 472-9055
Root Cause
Equipment maintenance
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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