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FDA (Device enforcement)Recalled 2022-05-16class i

Draeger Medical, Inc.: Drager SafeStar 55, Catalog No. MP01790

Is my product affected?

Drager SafeStar 55, Catalog No. MP01790

  • UPC 04048675026785

Check against the official notice below — it lists the full affected range.

What happened

Draeger Medical, Inc. is recalling 35,950 units of the Drager SafeStar 55 (Catalog No. MP01790) worldwide, including distribution across numerous U.S. states and international countries. The recall was initiated due to a possible occlusion of filters caused by a manufacturing error. The affected product is identified by UDI-DI 04048675026785 and Lot No. LT2103.

The source document does not specify a remedy or instructions for what affected consumers should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Possible occlusion of filters due to manufacturing error.

Details from the source

Reason for recall: Possible occlusion of filters due to manufacturing error. 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, Phi Quantity: 35,950 Lot/code info: UDI-DI: 04048675026785; Lot No. LT2103.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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