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.
Enforcement
- Recall Number
- Z-0487-2015
- Event ID
- 69648
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Beevers Manufacturing & Supply, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- December 10, 2014
- Initiation Date
- January 18, 2007
- Classification Date
- December 1, 2014
- Termination Date
- December 1, 2014
- Address
- 850 SW Booth Bend Rd, N/A, McMinnville, OR, 97128-9320, United States
Description
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.
Cannulaide model CA 101 was recalled because the firm discovered this model was packed and labeled as CA 102.
Lot 20060928. Product expired in 2009.
Worldwide Distribution: US (nationwide) and country of: ME-Musaffah.
393 units