Recall Z-0483-2015— Beevers Manufacturing & Supply, Inc.
Class II · Terminated
Class II FDA medical device recall by Beevers Manufacturing & Supply, Inc., initiated 2008-05-13, terminated 2014-11-28. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Beevers Manufacturing & Supply, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2008-05-13
- Terminated
- 2014-11-28
- Firm location
- McMinnville, OR, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.