{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "198353", "product_res_number": "Z-1213-2023", "event_date_initiated": "2023-02-01", "event_date_posted": "2023-03-03", "recall_status": "Open, Classified", "res_event_number": "91612", "product_code": "KDJ", "k_numbers": [ "K152129" ], "product_description": "Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis", "code_info": "UDI/DI 00085412007694, Lot numbers: GD912051, exp 31-Mar-2024; GD912068, exp 30-Apr-2024; GD912099, exp 30-Apr-2024; GD912112, exp 30-Apr-2024; GD912143, exp 30-Apr-2024; GD912204, exp 31-May-2024. \n\nExpansion on 05/10/2023: Product Code 5C4466P with all lots numbers manufactured prior to 09/30/2022.", "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": "MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals. This could lead to exposure to air, resulting in insufficient iodine/dry sponge inside the MiniCap, which could lead to the potential for inadequate disinfectant.", "root_cause_description": "Process control", "action": "Baxter Healthcare initiated the recall by issuing an Urgent Medical Device Recall notice to its consignees by letter on 02/01/2023. The notice requested the following from customers: \n1. Check your stock and set aside all product with the affected lot numbers. \n2. Contact Baxter HomeCare Services to arrange for return of impacted product and for ordering replacement product. \n3. If all of your product is impacted by this recall and you are unable to get unaffected lot numbers, resulting in a significant delay in therapy, please follow the below steps:\na. Contact your clinic for clinical guidance and check each pouch and do not use the MiniCap contained inside of any pouches that appear to have damaged seals.\nFor general questions regarding this communication, contact Baxter Corporate Product Surveillance at 800-437-5176, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday.\"\n\nRecall was expanded and Baxter Healthcare sent an updated notification to customers and patients on 05/09/2023. The letter instructed consignees and patients to immediately cease use of the affected product, arrange for the return of affected product and assess each patient's individual next steps based on clinical evaluation. Customers were also instructed to complete the customer response form via the portal (for products directly received from Baxter) or through the distributor. If the products were further distributed, please notify customers.", "product_quantity": "33,866,400 units", "distribution_pattern": "US Nationwide distribution and Canada.", "openfda": { "k_number": [ "K883393", "K811863", "K852678", "K791426", "K812772", "K895990", "K042900", "K820546", "K893231", "K041792", "K860700", "K152129", "K791722", "K972731", "K900226", "K871155", "K781755", "K903869", "K801881", "K812771", "K902451", "K173651", "K892872", "K803300", "K812802", "K810600", "K772236", "K900242", "K871154", "K896600", "K871050", "K812130", "K780082", "K900106", "K871583", "K900140", "K896764", "K871049", "K780957", "K974387", "K022412", "K810670", "K870145", "K151620", "K893712", "K231849", "K810840", "K882455", "K921818", "K853550", "K896956", "K250404", "K801193", "K895673", "K920029", "K192705", "K921052", "K920586", "K900005", "K904806", "K173593", "K883239", "K031676", "K963668", "K925403", "K900142", "K896599", "K930843", "K771482", "K945567", "K792651", "K895992", "K902526", "K860230", "K800993", "K912208", "K895792", "K083542", "K900295", "K892870", "K791512", "K900012", "K810671", "K892871", "K961825", "K900243", "K791899", "K900006", "K811294", "K801220", "K895631", "K894783", "K851207", "K900141", "K152675", "K873984", "K972579", "K851208", "K915304", "K813069", "K173363", "K870626", "K895991", "K900004", "K896763", "K882498", "K896761", "K124024", "K214016", "K900323", "K915628", "K900008", "K772136" ], "registration_number": [ "3035708507", "1019003", "3005941719", "8030639", "3002907620", "9611823", "8030665", "2314912", "9612168", "9680579", "3032828299", "3039353681", "3003504604", "3016096143", "1650907", "3015335038", "3013188547", "1649518", "3038277270", "1058584", "3004111573", "1225714", "3038195011" ], "fei_number": [ "3035708507", "3001451489", "1019003", "3001236277", "3002907620", "1000219637", "2314912", "6898", "3002681132", "3032828299", "3002807744", "3003504604", "3039353681", "3016096143", "1000203464", "3002806471", "3015335038", "3002807111", "3013188547", "3002807005", "3038277270", "3004111573", "3038195011" ], "device_name": "Set, Administration, For Peritoneal Dialysis, Disposable", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5630", "device_class": "2" } } ] }