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U.S. Department of Health and Human Services

Class 2 Device Recall Cannulaide, Model 101.

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  Class 2 Device Recall Cannulaide, Model 101. see related information
Date Initiated by Firm January 18, 2007
Date Posted December 02, 2014
Recall Status1 Terminated 3 on December 01, 2014
Recall Number Z-0487-2015
Recall Event ID 69648
Product Classification Ventilator, non-continuous (respirator) - Product Code BZD
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.
Code Information Lot 20060928. Product expired in 2009.
Recalling Firm/
Manufacturer		 Beevers Manufacturing & Supply, Inc.
850 SW Booth Bend Rd
McMinnville OR 97128-9320
For Additional Information Contact Aurelia Brownridge
760-795-7102
Manufacturer Reason
for Recall		 Cannulaide model CA 101 was recalled because the firm discovered this model was packed and labeled as CA 102.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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