Home / Recalls / Medical Devices
ConvaTec, Inc recalls Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gass
Recalled March 9, 2016 · FDA recall Z-1044-2016 · ConvaTec
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. · FDA Class II
Units
3,605,700 pieces
Sold at
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.
Description
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.
Product
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.
Manufacturer(s)
ConvaTec, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →