Z-0007-2017 Class I Terminated

Recalled by Baxter Corporation Englewood — Englewood, CO

Recall Details

Product Type
Devices
Report Date
October 12, 2016
Initiation Date
August 24, 2016
Termination Date
July 26, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
202,647

Product Description

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.

Reason for Recall

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.

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.

Code Information

All unexpired lots-Product Code: H93835