Device 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.
Z-0487-2015
Product summary
- Event
- Event 69648
- Status
- Terminated
- Classification
- Class II
- Quantity
- 393 units
- Official record key
device-enforcement:Z-0487-2015
Official wording
Reason: Cannulaide model CA 101 was recalled because the firm discovered this model was packed and labeled as CA 102.
Code information: Lot 20060928. Product expired in 2009.
Distribution pattern: Worldwide Distribution: US (nationwide) and country of: ME-Musaffah.
Derived failure modes
-
Unknown
Cannulaide model CA 101 was recalled because the firm discovered this model was packed and labeled as CA 102.