Z-1211-2022 Class I Ongoing

Recalled by Draeger Medical, Inc. — Telford, PA

Recall Details

Product Type
Devices
Report Date
June 22, 2022
Initiation Date
May 16, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
35,950

Product Description

Drager SafeStar 55, Catalog No. MP01790

Reason for Recall

Possible occlusion of filters due to manufacturing error.

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.

Code Information

UDI-DI: 04048675026785; Lot No. LT2103.