Recall Z-0487-2015— Beevers Manufacturing & Supply, Inc.

Class II FDA medical device recall by Beevers Manufacturing & Supply, Inc., initiated 2007-01-18, terminated 2014-12-01. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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.

Classification

Class II

Status

Terminated

Initiated

2007-01-18

Terminated

2014-12-01

Firm location

McMinnville, OR, United States

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