Device product
0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
Z-0007-2017
Product summary
- Event
- Event 75031
- Status
- Terminated
- Classification
- Class I
- Quantity
- 202,647
- Official record key
device-enforcement:Z-0007-2017
Official wording
Reason: Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the 50mm 0.2 Micron Filter (Product Code: H93835) due to the potential for the filter membrane layer to be missing and for particulate matter to be present.
Code information: All unexpired lots-Product Code: H93835
Distribution pattern: Worldwide Distribution - US (Nationwide) and countries of: Austria, Belgium, Czech Republic, Denmark, Finland, Germany, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and United Kingdom.
Derived failure modes
-
Foreign material or chemical contamination
particulate matter