Recall Z-0483-2015 ยท BZD Ventilator, Non-Continuous (Respirator)
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 no
| Date | Dec 1, 2014 (initiated May 13, 2008) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.