Z-0487-2015 Class II Terminated

Recalled by Beevers Manufacturing & Supply, Inc. — McMinnville, OR

Recall Details

Product Type
Devices
Report Date
December 10, 2014
Initiation Date
January 18, 2007
Termination Date
December 1, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
393 units

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.

Distribution Pattern

Worldwide Distribution: US (nationwide) and country of: ME-Musaffah.

Code Information

Lot 20060928. Product expired in 2009.