Beevers Manufacturing & Supply, Inc.

Lot 20060928. Product expired in 2009.

Anesthesiology Devices

2

No

Worldwide Distribution: US (nationwide) and country of: ME-Musaffah.

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.

CA 101: Lot 54219; CA 102: Lot 52834; CA 103: Lot 53813;

Anesthesiology Devices

2

No

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.

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.

Recalled units include: LW102 (medium), Lot 66812; LW103 (large), Lots 66813 and 30660; and  LW105 (extra large), Lot 67879.  LumaWrap models with an adhesive strip (LW102 and LW103) have a 2-year shelf life.

General Hospital and Personal Use Devices

2

No

Product was distributed to US, Germany, Austria, France, Italy, Spain, Australia.

Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.