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U.S. Department of Health and Human Services

Class 1 Device Recall 0.2 Micron Filter, 50 mm

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  Class 1 Device Recall 0.2 Micron Filter, 50 mm see related information
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 and Original Applicant = BAXA CORP., SUB. OF COOK GROUP, INC.
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