{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "204365", "product_res_number": "Z-0512-2024", "event_date_initiated": "2023-11-06", "event_date_posted": "2023-12-20", "recall_status": "Open, Classified", "res_event_number": "93434", "product_code": "NGT", "k_numbers": [ "K201286" ], "product_description": "0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240", "code_info": "Product Code/UDI-DI/Lot: EMZ10091240/20363807109166/21112364, 21112439, 21112455, 21122507, 21122551, 21122576, 21122593, 21122609, 21122617, 22012635, 22073671, 22094119, 22104179, 22104234", "firm_fei_number": "3002695476", "recalling_firm": "Nurse Assist, LLC", "address_1": "4409 Haltom Rd", "city": "Haltom City", "state": "TX", "postal_code": "76117-1207", "additional_info_contact": "Michelle Smith\n800-649-6800 Ext. 120", "reason_for_recall": "Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.", "root_cause_description": "Process control", "action": "On 11/6/23, the firm issued a press release.\n\nOn 11/09/23, \"URGENT: MEDICAL DEVICE RECALL\" notices and response forms were emailed and mailed to direct customers and distributors, who were provided with a separate customer recall notice they could forward to their customers. \n\nCustomers were asked to do the following:\n1) Quarantine and then return affected devices.\n2) If affected products were further distributed, send these customers the attached recall notice that asks customers to return affected devices to their distributors.\n3) Distributors are asked to follow up with customers to ensure they received the recall notification and are taking appropriate action.\n4) Distributors are asked to provide their Customer Shipment Report that lists all devices shipped to customers. The report should include the Shipment Date, Customer Name and Address, Part Number, Lot Number, and Quantity. This information is important to determine removal effectiveness.\n5) Complete and return the response form via email to nurseassist@rqa-inc.com \n6) If your company repacked these medical devices into convenience kits, please contact your local FDA recall coordinator to evaluate the need for a new recall.\n\nThe firm is arranging for removal and replacement of the affected product.\n\nThe recall notice sent by distributors to their customers also asks that the notice be forwarded to the applicable personnel in their organization or to any organization where the Affected Devices were transferred. \n\nCustomers with questions can call 800-649-6800, between the hours of 8am and 4:30pm (CST), or email productremovalinfo@nurseassist.com", "product_quantity": "3,360 Cases", "distribution_pattern": "US Nationwide Distribution: SC AZ, CA, FL, GA, HI, IA, IN, KS, KY, MA, ME, MN, MS, NC, ND, NE, NJ, NV, NY, OH, PA, RI, TX, WA, WI, AK, AL, AR, CO, CT, DC, ID, IL, LA, MD, MI, MO, MT, NH, NM, OK, OR, PR, SD, TN, UT, VA , WI, WV, WY.\n\nOUS (foreign) distribution to: Canada", "openfda": { "k_number": [ "K213522", "K042061", "K113555", "K161552", "K142620", "K011283", "K153481", "K191378", "K223584", "K231724", "K082689", "K082837", "K020996", "K183473", "K250884", "K060339", "K101270", "K192414", "K133685", "K103740", "K231161", "K141311", "K173348", "K214080", "K020999", "K121262", "K120836", "K121050", "K150143", "K231754", "K121231", "K231363", "K032438", "K090882", "K171109", "K091583", "K230756", "K233623", "K201286", "K111034" ], "registration_number": [ "3036113190", "3010882708", "3007590959", "3016972038", "1055236", "3020460367", "1526711", "2027791", "2518902", "3002907620", "3007163376", "3016413378", "3016707060", "3012421607", "1057300", "3043709866", "3036706541", "3010407203", "3008518459", "1911916", "3009848807", "3017509841", "3038181770", "1043214", "3016741564", "1047843", "3036757319", "1423982", "3034669683", "3005934752", "1054241", "2320762", "1649518", "3004756837", "3011508621", "2243072", "3014421917", "3010405396", "1224960", "3025432964", "3015751263", "3005806438", "1650927", "3012494290", "9680794", "1423507", "3004080548", "3015060216", "9616657", "1423662", "3002682307", "3005669815" ], "fei_number": [ "1000151124", "3010882708", "3007590959", "3016972038", "3036113190", "3020460367", "1526711", "2518902", "3002907620", "3007163376", "3016413378", "3016707060", "3012421607", "3005698992", "3043709866", "3036706541", "3010407203", "3008518459", "3000215273", "1911916", "3009848807", "3017509841", "3038181770", "3008002452", "1000112968", "1043214", "3016741564", "1047843", "3036757319", "3000204727", "3034669683", "3005934752", "1000112877", "3002695476", "1000122362", "3004756837", "3011508621", "2243072", "3014421917", "3010405396", "3025432964", "3015751263", "3005806438", "3003737899", "3001677091", "3012494290", "3004080548", "3015060216", "3002682307", "3005669815", "3001236277", "3003040625" ], "device_name": "Saline, Vascular Access Flush", "medical_specialty_description": "General Hospital", "regulation_number": "880.5200", "device_class": "2" } } ] }