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U.S. Department of Health and Human Services

Class 2 Device Recall Cannulaide

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  Class 2 Device Recall Cannulaide see related information
Date Initiated by Firm May 13, 2008
Date Posted December 01, 2014
Recall Status1 Terminated 3 on November 28, 2014
Recall Number Z-0483-2015
Recall Event ID 69627
Product Classification Ventilator, non-continuous (respirator) - Product Code BZD
Product Cannulaide, Model 101, 102, 103. Respirator.

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 CA 101: Lot 54219; CA 102: Lot 52834; CA 103: Lot 53813;
Recalling Firm/
Manufacturer		 Beevers Manufacturing & Supply, Inc.
850 SW Booth Bend Rd
McMinnville OR 97128-9320
For Additional Information Contact Aurelia Brownridge
503-472-9055
Manufacturer Reason
for Recall		 Cannulaide recalled May 2008 due to improper seal of the pouch. The improper seal of the Cannulaide's package could potentially affect the device shelf life.
FDA Determined
Cause 2		 Equipment maintenance
Action Beevers Manufacturing & Supply, Inc. (BMS) did contact the customers via letter and phone call in May 2008. Customers that didn't reply were further contacted via email on June 2008. Salter Labs provided BMS' recall report to FDA in October 2014. Salter Labs was unable to locate a recall letter issued by BMS to the affected customers. For further questions please call (503) 472-9055
Quantity in Commerce 16,575 units total (15,625 units in US and 950 units outside US)
Distribution Worldwide Distribution - US Distribution including the states of LA, GA, OR, MA, NJ, FL and CA., and the countries of Canada, France, Japan, Netherlands and United Kingdom.
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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