Cannulaide, Model 101. The Cannulaide product is composed of die-cut hydrocolloid coated polyurethane film...
Beevers Manufacturing & Supply, Inc. began a recall of 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... on . FDA classified it as Class II and gives the reason as "Cannulaide model CA 101 was recalled because the firm discovered this model was packed and labeled as CA 102". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0487-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Beevers Manufacturing & Supply, Inc.
- Product
- 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 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 model CA 101 was recalled because the firm discovered this model was packed and labeled as CA 102.
- Root cause tag
- labeling and UDI
- FDA 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 in commerce
- 393 units
- Distribution
- Worldwide Distribution: US (nationwide) and country of: ME-Musaffah.
- Product codes and lots
- Lot 20060928. Product expired in 2009.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0487-2015 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
