| Class 1 Device Recall 0.2 Micron Filter, 50 mm |  |
Date Initiated by Firm | August 24, 2016 |
Date Posted | October 06, 2016 |
Recall Status1 |
Terminated 3 on July 26, 2017 |
Recall Number | Z-0007-2017 |
Recall Event ID |
75031 |
510(K)Number | K900585 |
Product Classification |
Set, i.V. Fluid transfer - Product Code LHI
|
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. |
Code Information |
All unexpired lots-Product Code: H93835 |
Recalling Firm/ Manufacturer |
Baxter Corporation Englewood 14445 Grasslands Dr Englewood CO 80112-7062
|
For Additional Information Contact | Center for One Baxter 800-422-9837 |
Manufacturer 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. |
FDA Determined Cause 2 | Nonconforming Material/Component |
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 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. |
Quantity in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = LHI
|
|
|
|