Cannulaide, Model 101. The Cannulaide product is composed of die-cut hydrocolloid coated polyuret...
FDA Recall #Z-0487-2015 — Class II — January 18, 2007
Product 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 for Recall
Cannulaide model CA 101 was recalled because the firm discovered this model was packed and labeled as CA 102.
Recalling Firm
Beevers Manufacturing & Supply, Inc. — McMinnville, OR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
393 units
Distribution
Worldwide Distribution: US (nationwide) and country of: ME-Musaffah.
Code Information
Lot 20060928. Product expired in 2009.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated