FDA Recall Terminated

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.

Recall: Z-0007-2017 · Initiated August 24, 2016

Recall

Recall Number
Z-0007-2017
Event Number
75031
Firm
Baxter Corporation Englewood
FEI Number
1419106
Product Code
LHI
Status
Terminated
Root Cause
Nonconforming Material/Component
Initiated
August 24, 2016
Posted
October 6, 2016
Terminated
July 26, 2017
Address
14445 Grasslands Dr, Englewood, CO, 80112-7062

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

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.

Action

The firm, Baxter, sent an "URGENT PRODUCT RECALL" letter dated 8/24/2016 to its Consignees/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) locate and remove all affected product; 2) contact Baxter Health Care Center for Service to arrange for return of product at 888-229-0001 between the hours of 7am-6pm Central Time, Monday-Friday; 3) Complete and return the Customer Reply form to Baxter via fax to 224-270-5457 or scan and email to [email protected], and 4) if you distributed this product to others facilities or department within your institutions forward copy of the communication. For general questions, contact Baxter Product Surveillance at 800-437-5176 between the hours of 8am-5pm Central Time, Monday through Friday.

Distribution

Worldwide Distribution - US (Nationwide) and countries of: Austria, Belgium, Czech Republic, Denmark, Finland, Germany, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and United Kingdom.

Quantity

202,647