{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "220720", "product_res_number": "Z-2702-2026", "event_date_initiated": "2026-05-11", "event_date_posted": "2026-07-08", "recall_status": "Open, Classified", "res_event_number": "99061", "product_code": "KDI", "k_numbers": [ "K243505" ], "product_description": "5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions.\n\n1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6.\n\n2. 5008X HD Pre-Flush With Twister Blood Tubing Set; Model Number: 03-5160-1. \n\n3. 5008X HD/HDF Standard Blood Tubing Set; Model Number: 03-5300-3. \n\n4. 5008X HD/HDF With CLiC Blood Tubing Set; Model Number: 03-5300-3C. \n\n5. 5008X HD/HDF With Twister Blood Tubing Set; Model Number: 03-5350-8.", "code_info": "Sets manufactured after February 26, 2026\n\n1. Model Number: 03-5110-6. UDI-DI: 00840861102556. \n\n2. Model Number: 03-5160-1. UDI-DI: 00840861102563. \n\n3. Model Number: 03-5300-3. UDI-DI: 00840861102518. \n\n4. Model Number: 03-5300-3C. UDI-DI: 00840861102532. \n\n5. Model Number: 03-5350-8. UDI-DI: 00840861102525.", "firm_fei_number": "3001451489", "recalling_firm": "Fresenius Medical Care Holdings, Inc.", "address_1": "920 Winter St Bld 920", "city": "Waltham", "state": "MA", "postal_code": "02451-1521", "additional_info_contact": "Fresenius Medical Care Customer Service\n800-323-5188", "reason_for_recall": "Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.", "root_cause_description": "Process control", "action": "Fresenius Medical Care notified consignees on about 05/11/2026 via \"IMPORTANT MEDICAL DEVICE INFORMATION\" letter. Consignees were informed of the issue of potential Online Port Errors and additional information to support proper connection of the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem. \n\nWhen pushing the substitution fluid connector (SafeLineTM) into the substitution fluid port, firmly insert the substitution fluid connector until you feel resistance. Check that there is no visible gap between the ring of the connector and the module. In\nthe case of a visible gap between the ring of the connector and the module surface, apply\npressure and push the connector to close the gap before automatic closure of the substitution fluid port door. \n\nFresenius Medical Care is assessing improvements to restore the usual handling and user\nexperience. FMCRTG is not requesting return of any product.\n\n***Update***\n\nOn June 29, 2026, the firm sent a follow-up letter to consignees via First Class Mail.\n\nThe updated letter states the firm has initiated shipments of limited quantities of new unaffected product.\n\nCustomers are instructed to preferentially use unaffected lots of the tubing sets. If the customer needs to administer treatment and there are no alternatives available, they may use the affected lots of tubing sets to provide therapy, but only if they follow the specific instructions for using these affected sets.\n\nUnaffected lots of product do not require additional effort to seat the connector into the port.", "product_quantity": "113,544 units (4,731 cases)", "distribution_pattern": "US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, PA, TX, VA.", "openfda": { "k_number": [ "K840543", "K210575", "K992894", "K162248", "K000724", "K173972", "K800536", "K130039", "K813591", "K921134", "K170574", "K920757", "K252459", "K854586", "K232803", "K031378", "K171331", "K853333", "K100334", "K994198", "K970591", "K926373", "K820243", "K945597", "K780527", "K980859", "K032356", "K923139", "K823338", "K113427", "K850866", "K190793", "K123262", "K131908", "K830647", "K123395", "K011221", "K080650", 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"876.5860", "device_class": "2" } } ] }