{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 61 } }, "results": [ { "cfres_id": "149142", "product_res_number": "Z-0007-2017", "event_date_initiated": "2016-08-24", "event_date_posted": "2016-10-06", "recall_status": "Terminated", "event_date_terminated": "2017-07-26", "res_event_number": "75031", "product_code": "LHI", "k_numbers": [ "K900585" ], "product_description": "0.2 Micron Filter, 50 mm\n\nProduct Usage:\nThe 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.", "code_info": "All unexpired lots-Product Code: H93835", "firm_fei_number": "1419106", "recalling_firm": "Baxter Corporation Englewood", "address_1": "14445 Grasslands Dr", "city": "Englewood", "state": "CO", "postal_code": "80112-7062", "additional_info_contact": "Center for One Baxter\n800-422-9837", "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.", "root_cause_description": "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: \n1) 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.\n\nFor general questions, contact Baxter Product Surveillance at 800-437-5176 between the hours of 8am-5pm Central Time, Monday through Friday.", "product_quantity": "202,647", "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.", "openfda": { "k_number": [ "K013087", "K252987", "K090905", "K010703", "K203674", "K024239", 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