{ "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": 1 } }, "results": [ { "cfres_id": "196010", "product_res_number": "Z-0083-2023", "event_date_initiated": "2022-09-14", "event_date_posted": "2022-10-12", "recall_status": "Open, Classified", "res_event_number": "90841", "product_code": "KDI", "k_numbers": [ "K042938" ], "product_description": "Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142). For use in providing continuous fluid management and renal replacement therapies.", "code_info": "UDI 07332414069254 (product code 107140), 07332414069315 (product code 107142); All Lot Codes", "firm_fei_number": "1417572", "recalling_firm": "Baxter Healthcare Corporation", "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": "Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.", "root_cause_description": "Error in labeling", "action": "Baxter sent an Urgent Medical Device Correction notice to its direct consignees by USPS on 09/14/2022. The notice explained the Estonian translation issue and requested that the following actions be taken by consumers:\n1. Use of the Prismaflex HF20 set should be restricted to patients with a body weight greater than 8kg (18lb).\nUse of the Prismaflex M60 and ST60 sets should be restricted to patients with a body weight greater than 11kg (24lb).\nUse of the Prismaflex M100, ST100, M150, ST150, HF1000 and HF1400 sets should be restricted to patients with a body weight greater than 30kg (66lb).\n2. Customers who are not referring to the Estonian IFU should continue to follow the IFU instructions in their language.\n3. If you received this communication directly from Baxter, please acknowledge receipt by responding on our customer portal at\nhttps://BaxterFieldActionCustomerPortal.onprocess.com/. \n4. If you purchased this product from a distributor, please note that responding via\nthe Baxter customer portal is not applicable. If a response is requested by your\ndistributor or wholesaler, please respond to the supplier according to their\ninstructions.\n5. If you distribute this product to other facilities or departments within your institution,\nplease forward a copy of this communication to them.\n6. If you are a dealer, wholesaler, distributor/reseller, or original equipment\nmanufacturer (OEM) that distributed any affected product to other facilities, please\nnotify your customers of this Urgent Medical Device Correction in accordance with\nyour customary procedures and check the associated box on the customer\nportal.", "product_quantity": "328,300 devices", "distribution_pattern": "US Nationwide", "openfda": { "k_number": [ "K861106", "K062090", "K981681", "K801479", "K853333", "K160881", "K952982", "K830595", "K231406", "K243874", "K170469", "K884353", "K131516", "K964922", "K050525", "K050609", "K854309", "K952342", "K131935", "K800536", "K082414", "K183158", "K113023", "K832547", "K140191", "K900918", "K261267", "K013418", "K832659", "K131050", "K952978", "K992894", "K973516", "K840680", "K131908", "K122343", "K923312", "K863961", "K242155", "K060195", "K971180", "K093902", "K083778", "K844790", "K840543", "K903641", "K933883", "K873887", "K830284", "K982413", "K240394", 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