0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions

FDA device recall Z-0007-2017 · posted 2016-10-06 · Terminated

Recall details

Recalling firm

Baxter Corporation Englewood

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.

Action taken

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 fca@baxter.com, 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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LHI

Quantity affected

202,647

Distribution

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

Date initiated

2016-08-24

Date posted

2016-10-06

Date terminated

2017-07-26

Location

Englewood, CO

Related 510(k) clearances