Draeger, Inc.: HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.

Hazard

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

Details from the source

Reason for recall: Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. Distribution: Worldwide - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, ID, IL, IN, KAS, LA, MA, ME, MI, MN, MO, NC, NE, NM, NV, NY, OH, PA, SD, TN, TX, UT, WA, WI, WY and the countries of Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina-Faso, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominic Quantity: 1,019,782 units Lot/code info: Model No. MP05801; UDI: 04048675665823; All Lots.

UPC codes

04048675665823

Source

Official record: FDA (Device enforcement) ↗

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