Draeger Medical, Inc. Recall 90192
Description: Drager SafeStar 55, Catalog No. MP01790
Draeger Medical, Inc. Recall 90192 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1211-2022 |
| Event ID | 90192 |
| Event Description | Drager SafeStar 55, Catalog No. MP01790 |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 35,950 |
| Recall Reason | Possible occlusion of filters due to manufacturing error. |
| Device Classification | 20220622 |
| Device Code Info | UDI-DI: 04048675026785; Lot No. LT2103. |
| Center Classification Date | 20220610 |
| Recall Initiation Date | 20220516 |
| Recalling Firm | Draeger Medical, Inc. |
| Initial Notification | Letter |
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