FDAClass IJune 22, 2022

Drager SafeStar 55 recall

Drager SafeStar 55, Catalog No. MP01790

Why was Drager SafeStar 55 recalled?

Possible occlusion of filters due to manufacturing error.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 04048675026785; Lot No. LT2103.

Product
Drager SafeStar 55, Catalog No. MP01790
Recalling firm
Draeger Medical, Inc.
Quantity
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.
Recall date
June 22, 2022
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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