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Draeger Medical, Inc. Recall 90192

Description: Drager SafeStar 55, Catalog No. MP01790

Draeger Medical, Inc. Recall 90192 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1211-2022
Event ID90192
Event DescriptionDrager SafeStar 55, Catalog No. MP01790
Product TypeDevices
DistributionWorldwide 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.
Recall ReasonPossible occlusion of filters due to manufacturing error.
Device Classification20220622
Device Code InfoUDI-DI: 04048675026785; Lot No. LT2103.
Center Classification Date20220610
Recall Initiation Date20220516
Recalling FirmDraeger Medical, Inc.
Initial Notification Letter
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