Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0487-2015Class II

Cannulaide, Model 101. The Cannulaide product is composed of die-cut hydrocolloid coated polyurethane film...

Beevers Manufacturing & Supply, Inc. / initiated 2007-01-18 / Terminated / root cause: labeling and UDI

Beevers Manufacturing & Supply, Inc. began a recall of 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... on . FDA classified it as Class II and gives the reason as "Cannulaide model CA 101 was recalled because the firm discovered this model was packed and labeled as CA 102". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0487-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Beevers Manufacturing & Supply, Inc.
Product
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.
Product code
BZD Ventilator, Non-Continuous (Respirator)
Reason for recall
Cannulaide model CA 101 was recalled because the firm discovered this model was packed and labeled as CA 102.
Root cause tag
labeling and UDI
FDA root cause
Labeling Change Control
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.
Quantity in commerce
393 units
Distribution
Worldwide Distribution: US (nationwide) and country of: ME-Musaffah.
Product codes and lots
Lot 20060928. Product expired in 2009.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0487-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0487-2015Class IITerminatedVoluntary: Firm initiated