Cannulaide, Model 101, 102, 103. Respirator. The Cannulaide product is composed of die-cut h...
FDA Device Recall #Z-0483-2015 - Class II, May 13, 2008
Recall Summary
| Recall Number | Z-0483-2015 |
| Classification | Class II - Moderate risk |
| Date Initiated | May 13, 2008 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Beevers Manufacturing & Supply, Inc. |
| Location | McMinnville, OR |
| Product Type | Devices |
| Quantity | 16,575 units total (15,625 units in US and 950 units outside US) |
Product Description
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 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.
Distribution Pattern
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.
Lot / Code Information
CA 101: Lot 54219; CA 102: Lot 52834; CA 103: Lot 53813;
Other Recalls from Beevers Manufacturing & Supply, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2181-2014 | Class II | Luma Wrap Phototherapy Swaddler is designed to ... | Jul 11, 2014 |
| Z-0487-2015 | Class II | Cannulaide, Model 101. The Cannulaide product i... | Jan 18, 2007 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.