FDA Medical Device Recalls (openFDA)
Beevers Manufacturing & Supply, Inc.: 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.
- Recall number
- Z-0483-2015
- Recalling firm
- Beevers Manufacturing & Supply, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2008-05-13
- Posted
- 2014-12-01
- Terminated
- 2014-11-28
- Reason
- 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.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- CA 101: Lot 54219; CA 102: Lot 52834; CA 103: Lot 53813;
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BZD
- Firm FEI
- 3023468
- Firm city
- McMinnville
- Firm state
- OR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28