{ "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": "184202", "product_res_number": "Z-0483-2021", "event_date_initiated": "2020-10-05", "event_date_created": "2020-11-23", "recall_status": "Terminated", "event_date_terminated": "2021-03-19", "res_event_number": "86619", "product_code": "DXT", "k_numbers": [ "K192370" ], "product_description": "Brand Name: MEDRAD Stellant FLEX Syringe Kits\n\nCommon Name: Angiographic Syringe\n\nCatalog/REF Number: FLEXD-150-SCS\nDescription: 2 - 150 mL FLEX syringes, 1 large saline spike, 1 small contrast spike, patient t-connector tubing & prime tube.\n\nCatalog/REF Number: FLEXD-150-SPK\nDescription: 2 - 150 mL FLEX syringes, 2 small spikes, patient t-connector tubing & prime tube.", "code_info": "Catalog/REF Number: FLEXD-150-SCS  Material Number: 87078817  Lot Numbers: 8584324, 8586383, 8586384, 8586385,   8586386, 8586388   UDI Numbers:   (01)00616258022888(11)200620(17)240620(10)8584324  (01)00616258022888(11)200620(17)240620(10)8584324  (01)00616258022888(11)200620(17)240620(10)8584324  (01)00616258022888(11)200620(17)240620(10)8584324  (01)00616258022888(11)200620(17)240620(10)8584324  (01)00616258022888(11)200620(17)240620(10)8584324  Catalog/REF Number: FLEXD-150-SPK Material Number: 85020218 Lot Number: 8585234  UDI Numbers: (01)00616258010656(11)200720(17)240720(10)8585234", "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": "Julia Mitchell\n724-940-7890", "reason_for_recall": "Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe.", "root_cause_description": "Process control", "action": "On 10/08/020, Bayer sent all of their affected customers an Urgent Medical Device Field Corrective Action (recall) letter via e-mail. The recall letter requested that all of the affected customers immediately take the following steps:\n\n1. Review your current inventory. Quarantine any affected batch/lot numbers referenced in the below chart. Instructions are included in this letter on how to identify batch/lot.\n\n2. Complete the included response form and submit through email to CLSCRiCustomerLogistics@bayer.com or contact the Customer Logistics team at 724-940-7890. Please complete the Customer Response Form regardless of whether you have affected product or not. This action will assist us in tracking all affected product.\n\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.\n If product is needed immediately to avoid a stock out, expedited shipping \n options will be available. For expedited shipping options, please contact the \n Customer Logistics team at 724-940-7890.\n\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 the RGA number.\n\n5. Upon Bayer receipt of return product, you will receive a credit on your account.\n\nPlease distribute this letter to other appropriate departments and personnel within your institution who may have inventory that may be affected by this field corrective action.", "product_quantity": "92,420 units", "distribution_pattern": "Distributed to healthcare facilities nationwide throughout the US.", "openfda": { "k_number": [ "K823356", "K791793", "K955684", "K821401", "K173450", "K883769", "K022116", "K062168", "K120892", "K920135", "K000013", "K001663", "K913624", "K090487", "K910873", "K132928", "K083523", "K093830", "K140469", "K151960", "K880493", "K841493", "K984088", "K152978", "K984231", "K252652", "K203004", "K033881", "K823238", "K183267", "K152218", "K170431", "K800613", "K860204", "K881521", "K163054", "K822536", "K172694", "K903390", "K863037", "K211564", "K863596", "K895318", "K830754", "K181936", "K911549", "K173773", "K903495", "K142745", "K873687", "K991557", "K964642", 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"3005747797", "3006950086", "3002963732", "3013820501", "1643817", "3015173212", "3003040625" ], "device_name": "Injector And Syringe, Angiographic", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1650", "device_class": "2" } } ] }