FDA-Device2016-03-09Class II
Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.
ConvaTec, Inc
Hazard
The Nebulizer mask malfunctions in that there is reduced or no aerosol output. The malfunction occurs from the reduction in the diameter of a component part inside the nebulizer.
Sold states
Worldwide Distribution: US (nationwide) including states of: AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, ME, MA, MN, MS, MO, NV, NH, NJ, NY, NC, OH, OR, PA, SC, TX VA, WA, WI, and countries of: Australia, Belgium, Burma, Canada, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, Germany, Israel, Italy, Jordan, Kenya, Kuwait, Netherlands, Norway, Russia, Saudi Arabia, Sweden, Switzerland, United Kingdom & Vietnam.
Affected count
3,605,700 pieces
Manufactured in
7900 Triad Center Dr Ste 400, N/A, Greensboro, NC, United States
Products
Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1044-2016Don't want to check this manually?
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