{ "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": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "133954", "product_res_number": "Z-1269-2015", "event_date_initiated": "2015-01-22", "event_date_posted": "2015-03-13", "recall_status": "Completed", "res_event_number": "70512", "product_code": "KDI", "k_numbers": [ "K895631" ], "product_description": "MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.", "code_info": "Lot Numbers: GD896845, Exp. 10/2015; GD897371, Exp. 01/2016; GD896936, Exp. 10/2015; GD897124, Exp. 11/2015; GD897165, Exp. 12/2015; GD897157, Exp. 12/2015; GD896944, Exp. 11/2015; GD896837, Exp. 10/2015", "firm_fei_number": "1417572", "recalling_firm": "Baxter Healthcare Corp.", "address_1": "1 Baxter Pkwy", "city": "Deerfield", "state": "IL", "postal_code": "60015-4625", "additional_info_contact": "Center for One Baxter \n800-422-9837", "reason_for_recall": "Product may have separating or protruding sponges", "root_cause_description": "Under Investigation by firm", "action": "Baxter sent an Urgent Product Recall letter dated January 22, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. \n\nBaxter is requesting that you take the following actions:\n\n1. Locate and remove all affected product from your facility. The product code and lot number can be found on the individual product package or shipping carton.\n2. Contact Baxter Healthcare Center for Service to arrange for return and credit. Center for Service can be reached at 888-229-0001, Monday through Friday, between the hours of 7:00 AM and 6:00 PM Central Time. Please have your Baxter eight-digit ship-to account number ready when calling.\n3. If you received your product directly from Baxter, please complete the enclosed customer reply form, and return it to Baxter by either fax or scanned e-mail.\n\n1. If you ordered product from a dealer, wholesaler, or distributor/reseller, please follow your supplier's reply and recall process.\n2. Locate and remove all affected product from your facility. The product code and lot number can be found on the individual product package or shipping carton.\n3. Contact Baxter Healthcare Center for Service to arrange for return and credit.Center for Service can be reached at 888-229-0001, Monday through Friday, between the hours of 7:00 AM and 6:00 PM Central Time. Please have your ship-to account number ready when calling.\n4. Please do not return the Baxter customer reply form to Baxter. Reply forms should be returned to your supplier.\n\nFor clinical questions, contact Baxter's Renal Clinical Helpline at\n888-736-2543, option 2, Monday through Friday, between the hours of\n8:00 AM and 5:00 PM Central Time.\n\nFor general questions regarding this communication, contact The Center for One Baxter at 800-422-9837, Monday through Friday, between the hours of 8:00AM and 5:00 PM Central Time.", "product_quantity": "4,391,520 units", "distribution_pattern": "Worldwide Distribution - Nationwide Distribution and to the countries of : Canada, Austria, Norway, Portugal, Saudi Arabia and Spain.", "openfda": { "k_number": [ "K953996", "K010805", "K914020", "K964922", "K250508", "K863961", "K233335", "K162488", "K920757", "K945596", "K890315", "K123395", "K872767", "K192756", "K212216", "K213639", "K861776", "K220281", "K014152", "K051187", "K911094", "K801303", "K823589", "K034064", "K140191", "K210575", "K193005", "K233557", "K233798", "K121497", "K871108", "K955592", "K171331", 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