FDA-Device2022-06-22Class I
Drager SafeStar 55, Catalog No. MP01790
Draeger Medical, Inc.
Hazard
Possible occlusion of filters due to manufacturing error.
Sold states
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, NC, ND, NV, NY, OH, PA, TN, TX, WA, and WV. The countries of Austria, Belgium, Bulgaria, Canada, Columbia, Croatia, Czech Republic, Denmark, France, Germany, India, Indonesia, Ireland, Italy, Ivory Coast, Japan, Kazakhstan, Latvia, Malaysia, Morocco, Netherlands, Norway, Philippines, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Suriname, Sweden, Switzerland, Thailand, United Kingdom, and United Arab Emirates.
Affected count
35,950
Manufactured in
3135 Quarry Rd, Telford, PA, United States
Products
Drager SafeStar 55, Catalog No. MP01790
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1211-2022Don't want to check this manually?
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