Device product
Drager SafeStar 55, Catalog No. MP01790
Z-1211-2022
Product summary
- Event
- Event 90192
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 35,950
- Official record key
device-enforcement:Z-1211-2022
Official wording
Reason: Possible occlusion of filters due to manufacturing error.
Code information: UDI-DI: 04048675026785; Lot No. LT2103.
Distribution pattern: 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.
Derived failure modes
-
Manufacturing or process control
manufacturing error