FDA Device recall Z-0483-2015
Cannulaide, Model 101, 102, 103
- FDA Device
- Class II
- terminated
- Published 2014-12-03
On 2014-12-03 the FDA classified a Class II recall of Cannulaide, Model 101, 102, 103 by Beevers Manufacturing And Supply, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0483-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2008-05-13 |
| Published | 2014-12-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Beevers Manufacturing And Supply |
| Distribution | CA, FL, GA, LA, MA, NJ, OR |
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.
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.
Identifiers
| code_info | CA 101: Lot 54219; CA 102: Lot 52834; CA 103: Lot 53813; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0483-2015%22
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