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FDAFDA · Food and drugs·Recall number Z-1211-2022

Drager SafeStar 55, Catalog No. MP01790

Published June 22, 2022 · Recall initiated: May 16, 2022

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Possible occlusion of filters due to manufacturing error.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Draeger Medical, Inc.
Distributor
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.
Lot
UDI-DI: 04048675026785; Lot No. LT2103.
Risk classification
Class I
Area (FDA)
device
Country
United States

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