Device 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.
Z-0483-2015
Product summary
- Event
- Event 69627
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16,575 units total (15,625 units in US and 950 units outside US)
- Official record key
device-enforcement:Z-0483-2015
Official wording
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.
Code information: CA 101: Lot 54219; CA 102: Lot 52834; CA 103: Lot 53813;
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.
Derived failure modes
-
Unknown
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.