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Recall Observatory FDA recall evidence

Device product

Drager SafeStar 55, Catalog No. MP01790

Z-1211-2022

May 16, 2022

Class I

Product summary

Firm
Draeger Medical, Inc.
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

    reason.manufacturing_process_control · v1.0.0

    manufacturing error