{ "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": "210530", "product_res_number": "Z-0373-2025", "event_date_initiated": "2024-10-21", "event_date_posted": "2024-11-20", "recall_status": "Open, Classified", "res_event_number": "95525", "product_code": "KDJ", "k_numbers": [ "K152675" ], "product_description": "Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis", "code_info": "UDI/DI 00085412007731, Lot/Serial Numbers: All lots including and manufactured after H19I26088", "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": "Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like\n(NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain\nperitoneal dialysis and hemodialysis devices.", "root_cause_description": "Nonconforming Material/Component", "action": "Baxter issued an \"Important Medical Device Correction\" notice to consignees beginning on 10/21/2024 via letter. In February 2025, Baxter Kidney Care segment launched a standalone company, Vantive. Vantive issued an updated notice to consignees beginning on 2/19/25 via letter. The notice explained the issue, hazard involved, and requested the following actions be taken: For patients older than 6 months of age, healthcare providers are advised to continue using both the peroxide-cured silicone tubing version and/or the platinum-cured silicone tubing version of the MiniCap Extended Life PD transfer sets, as neither is anticipated to present safety risks related to PCB/PCBAs. 2. For patients younger than 6 months: a. Healthcare providers should prioritize the use of platinum-cured silicone tubing sets or other alternatives that may be available. b. If no alternatives are available, healthcare providers should continue to connect the peroxide-cured silicone tubing sets and prioritize the use of shorter transfer sets. c. If the patient currently has the peroxide-cured silicone tubing, they do not need to have it replaced early, as data demonstrates that PCBA levels decrease over treatment time. 3. If you received this communication directly from Vantive, please acknowledge receipt of this notification by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com, even if you do not have any remaining inventory. 4. If you purchased this product from a distributor, please note that responding via the Vantive customer portal is not applicable. 5. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers.", "product_quantity": "2,706,558 units", "distribution_pattern": "Worldwide Distribution (US Nationwide distribution)", "openfda": { "k_number": [ "K895991", "K860230", "K895990", "K892870", "K173363", "K883393", "K900106", "K871583", "K896599", "K772236", "K870145", "K800993", "K921818", "K900242", "K031676", "K894783", "K781755", "K041792", "K912208", "K812772", "K811863", "K896600", "K173593", "K945567", "K780957", "K801220", "K900006", "K810600", "K892871", "K772136", "K882455", "K851208", "K813069", "K925403", "K904806", "K812771", "K042900", "K811294", "K900295", "K972579", "K882498", "K900004", "K920586", "K791512", "K895792", "K780082", "K895992", "K853550", "K893712", "K820546", "K900005", "K022412", "K920029", "K900012", "K851207", "K895673", "K250404", "K900142", "K152675", "K810671", "K900140", "K871154", "K903869", "K152129", "K812802", "K972731", "K900008", "K852678", "K791722", "K803300", "K902526", "K896761", "K896764", "K151620", "K902451", "K915628", "K870626", "K173651", "K871155", "K771482", "K124024", "K214016", "K921052", "K893231", "K900226", "K900243", "K895631", "K871050", "K892872", "K791426", "K812130", "K791899", "K883239", "K860700", "K231849", "K961825", "K083542", "K810840", "K896763", "K974387", "K963668", "K873984", "K915304", "K896956", "K801881", "K900141", "K900323", "K810670", "K792651", "K871049", "K801193", "K930843", "K192705" ], "registration_number": [ "8030639", "8030665", "3038277270", "1650907", "1649518", "1019003", "3038195011", "2314912", "3013188547", "3016096143", "3005941719", "1225714", "3003504604", "3039353681", "9612168", "3032828299", "3002907620", "3015335038", "9680579", "9611823", "1058584", "3004111573", "3035708507" ], "fei_number": [ "1000219637", "3001236277", "3038277270", "3002806471", "1019003", "3002681132", "3038195011", "2314912", "3013188547", "3002807005", "3002807744", "3016096143", "1000203464", "6898", "3003504604", "3002807111", "3039353681", "3001451489", "3032828299", "3002907620", "3015335038", "3004111573", "3035708507" ], "device_name": "Set, Administration, For Peritoneal Dialysis, Disposable", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5630", "device_class": "2" } } ] }