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.
FDA Recall Z-0487-2015 · Posted 2014-12-02
Recalling FirmBeevers Manufacturing & Supply, Inc.
Recall StatusTerminated
Product CodeBZD
Date Initiated2007-01-18
Date Terminated2014-12-01
Product Quantity393 units
Reason for Recall
Cannulaide model CA 101 was recalled because the firm discovered this model was packed and labeled as CA 102.
Firm 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.
Root Cause
Labeling Change Control
Distribution Pattern
Worldwide Distribution: US (nationwide) and country of: ME-Musaffah.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.