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Recall Observatory FDA recall evidence

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

August 24, 2016

Class I

Product summary

Firm
Baxter Corporation Englewood
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

    reason.foreign_material_chemical_contamination · v1.0.0

    particulate matter