Reported Dec 3, 2014 · Terminated
Cannulaide, Model 101, 102, 103. Respirator. The Cannulaide product is composed of die-cut hydrocolloid-coated…
Beevers Manufacturing & Supply, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beevers Manufacturing & Supply, Inc. · 850 SW Booth Bend Rd · McMinnville, OR · 97128-9320
Is this the product you have?
- 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.
- Lot codes and dates
- CA 101Lot 54219
- CA 102Lot 52834
- CA 103Lot 53813
- Amount recalled
- 16,575 units total (15,625 units in US and 950 units outside US)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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