PlainRecalls
FDA Devices Critical Class I Ongoing

Drager SafeStar 55, Catalog No. MP01790

Reported: June 22, 2022 Initiated: May 16, 2022 #Z-1211-2022

Product Description

Drager SafeStar 55, Catalog No. MP01790

Reason for Recall

Possible occlusion of filters due to manufacturing error.

Details

Recalling Firm
Draeger Medical, Inc.
Units Affected
35,950
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.
Location
Telford, PA

Frequently Asked Questions

What product was recalled?
Drager SafeStar 55, Catalog No. MP01790. Recalled by Draeger Medical, Inc.. Units affected: 35,950.
Why was this product recalled?
Possible occlusion of filters due to manufacturing error.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 22, 2022. Severity: Critical. Recall number: Z-1211-2022.