Z-0483-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 3, 2014
- Initiation Date
- May 13, 2008
- Termination Date
- November 28, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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.
Code Information
CA 101: Lot 54219; CA 102: Lot 52834; CA 103: Lot 53813;