Z-0483-2015Class II

Cannulaide, Model 101, 102, 103. Respirator. The Cannulaide product is composed of die-cut...

Name: Z-0483-2015 Cannulaide, Model 101, 102, 103. Respirator. The Cannulaide product is composed of die-cut...
Creator: Beevers Manufacturing & Supply, Inc.
Published: 2008-05-13
License: https://open.fda.gov/license/

Beevers Manufacturing & Supply, Inc. / initiated 2008-05-13 / Terminated / root cause: manufacturing process

FDA source

Beevers Manufacturing & Supply, Inc. began a recall of Cannulaide, Model 101, 102, 103. Respirator. The Cannulaide product is composed of die-cut hydrocolloid-coated polyurethane film with an integral hook strip... on 2008-05-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0483-2015
Classification: Class II
Status: Terminated
Initiated: 2008-05-13
Posted: 2014-12-01
Terminated: 2014-11-28
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.
Product code: BZD Ventilator, Non-Continuous (Respirator)
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.
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: CA 101: Lot 54219; CA 102: Lot 52834; CA 103: Lot 53813;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0483-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0483-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-26

Product code BZD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)