{ "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": "176496", "product_res_number": "Z-0276-2020", "event_date_initiated": "2019-10-04", "event_date_created": "2019-11-04", "recall_status": "Open, Classified", "res_event_number": "83852", "product_code": "KDI", "k_numbers": [ "K072093" ], "product_description": "Prismaflex Control Unit, software versions below 7.21", "code_info": "Product Code: 107493; All Lot numbers; GTIN: 07332414073718", "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": "800-422-9837", "reason_for_recall": "Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.", "root_cause_description": "Software design", "action": "Baxter Healthcare notified customers on about 10/04/2019, via \"URGENT MEDICAL DEVICE CORRECTION\" letter. Customers were informed that Prismaflex Control Units with software versions 7.20 and below have the potential to produce communication errors. \n\nInstructions included that operators may continue to use the control units until the upgrade is performed, but if a communication error alarm does occur, follow the instructions presented on the graphical user interface and/or in the operators manual. It must be reinforced that it is important to manually return the extracorporeal blood to the patient, and re-train users on this process, outlined on page 10:57 of the operators manual, if necessary. A local Baxter service representative will contact your facility to determine the correction plan and schedule the software upgrade. \n\nIf the affected devices was purchased from Baxter, complete the provided Baxter Customer Reply Form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to fca@baxter.com. \n\nIf you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. For a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Correction in accordance with your customary procedures. \n\nQuestions regarding this recall can be directed to Baxter Corporate Product Surveillance at 800-437-5176, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday.", "product_quantity": "2,760 units", "distribution_pattern": "Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. \n\nInternational distribution to Australia, Bangladesh, Brunei, China, Hongkong, Indonesia, India, Japan, New Zealand, Taiwan, Korea, Singapore, Malaysia,\nMacau, Thailand, Vietnam, Canada, Argentina, Costa Rica, Cuba, Dominican Republic, Haiti, Barbados, Venezuela, St. Kitts, and EMEA.", "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", "K232803", "K852251", "K963440", "K830647", "K093964", "K923727", "K010131", "K962427", "K951311", "K090682", "K001283", "K992275", "K080519", "K193005", "K010805", "K854011", "K813591", "K980386", "K101715", "K243237", "K200741", "K884365", "K233798", "K000724", "K023874", "K990643", "K103832", "K945621", "K014152", "K994198", "K000028", "K182940", "K213639", "K243920", 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