FDA-Device2025-08-06Class I
SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
Draeger, Inc.
Hazard
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Sold states
Worldwide - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, ID, IL, IN, KAS, LA, MA, ME, MI, MN, MO, NC, NE, NM, NV, NY, OH, PA, SD, TN, TX, UT, WA, WI, WY and the countries of Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina-Faso, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep., El Salvador, Faeroe, France, French Guiana, Gabon, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Liechtenstein, Malaysia, Mali, Mexico, Moldavia, Mongolia, Morocco, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Turkey, Ukraine, United Kingdom, United Arab Emirates, Uzbekistan, Vietnam.
Affected count
9,885,139 units
Manufactured in
3135 Quarry Rd, Telford, PA, United States
Products
SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2159-2025Don't want to check this manually?
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