Recall Z-0487-2015 ยท BZD Ventilator, Non-Continuous (Respirator)
Beevers Manufacturing & Supply, Inc.
Cannulaide, Model 101. 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 m
| Date | Dec 2, 2014 (initiated Jan 18, 2007) |
| Status | Terminated |
| Reason | Cannulaide model CA 101 was recalled because the firm discovered this model was packed and labeled as CA 102. |
| Root cause | Labeling Change Control |
| Action | Beevers Manufacturing and Supply, Inc. (BMS) of McMinnville, Oregon, began notifying consignees about this recall on 1/18/2007. Customers were advised to inspect blue box that say size 2 (CA 102) and check if size 1 (CA 101) was packed inside. Salter Labs provided BMS' recall report to FDA in October 2014. |
| Quantity | 393 units |
| Distribution | Worldwide Distribution: US (nationwide) and country of: ME-Musaffah. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.