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Recall Observatory FDA recall evidence

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

January 18, 2007

Class II

Product summary

Firm
Beevers Manufacturing & Supply, Inc.
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

    reason.no_named_rule · v1.0.0

    Cannulaide model CA 101 was recalled because the firm discovered this model was packed and labeled as CA 102.