Device product
SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
Z-2159-2025
Product summary
- Firm
- Draeger, Inc.
- Event
- Event 97026
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 9,885,139 units
- Official record key
device-enforcement:Z-2159-2025
Official wording
Reason: Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Code information: Mode No. MP05790; UDI: 04048675558736; All Lots.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.