{ "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": "189597", "product_res_number": "Z-0199-2022", "event_date_initiated": "2021-09-14", "event_date_created": "2021-11-03", "recall_status": "Terminated", "event_date_terminated": "2023-01-19", "res_event_number": "88807", "product_code": "DXT", "k_numbers": [ "K132928" ], "product_description": "The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an accessory to the MEDRAD Mark 7 Arterion Injection System. It is designed to be loaded into the injector head of the injection system.", "code_info": "Batch number: 8415317", "firm_fei_number": "2520313", "recalling_firm": "Bayer Medical Care, Inc.", "address_1": "1 Bayer Dr", "city": "Indianola", "state": "PA", "postal_code": "15051-9702", "additional_info_contact": "SAME\n412-406-3305", "reason_for_recall": "Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)", "root_cause_description": "Packaging process control", "action": "Bayer issued Urgent Medical Device Recall Letter (Recall ID: SA-21-RAD-02) dated 9/14/21 via email. Letter states reason for recall, health risk and action to take:\nReview your current inventory for affected Lot 8415317 and quarantine, as appropriate.\n2. Complete the included response form and submit through email to\nCLSCRiCustomerLogistics@bayer.com or contact the Customer Logistics team at 724-940-7890.\nPlease complete the Customer Response Form regardless of whether you have affected\nproduct or not. This action will assist us in tracking all affected product.\n3. You will receive a Return Goods Authorization (RGA) number to return any affected Syringe kits remaining in your inventory for a credit. We can send new syringe kits with a separate purchase order, as necessary.\n4. Place the affected product in a box and label the outside of the container with the RGA number in large, bold writing. Use the shipping label provided via email when you receive your RGA number.\nPlease return affected product no later than November 30, 2021.\n5. Upon Bayer receipt of returned product, you will receive a credit on your account.\nPlease distribute this letter to other appropriate departments and personnel within your facility who may need to maintain awareness of this recall.", "product_quantity": "6,950 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of AU, BY, DE, DK, GB, HR, NL, \nNZ, RU, SE, TH.", "openfda": { "k_number": [ "K182273", "K863537", "K911166", "K905819", "K033247", "K863596", "K934086", "K023183", "K182289", "K113133", "K020892", "K062168", "K000013", "K203004", "K140469", "K904212", "K061976", "K072886", "K170431", "K163084", "K844045", "K171698", "K873597", "K924116", "K140425", "K890292", "K910873", "K984088", "K875324", "K912944", "K142081", "K833138", "K142745", "K232388", "K012950", "K873410", "K911549", "K964642", "K823253", "K973230", "K051799", "K090621", "K092896", "K133189", "K171646", "K823920", "K230668", "K822536", "K971712", "K252652", "K962141", 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"3011334555", "3007361214", "3015225571", "3002963732", "3009746061", "3009051888", "1526711", "3007048453" ], "device_name": "Injector And Syringe, Angiographic", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1650", "device_class": "2" } } ] }