{ "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": "216110", "product_res_number": "Z-0124-2026", "event_date_initiated": "2025-09-18", "event_date_posted": "2025-10-09", "recall_status": "Open, Classified", "res_event_number": "97550", "product_code": "OGE", "product_description": "Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: \n1. SESK PARKLAND MEMORIAL FX CSE TRAY. \n\n2. SESK OWENSBORO DAVIESS HOSP 20058814.\n\n3. SESK MEMORIAL HEALTH SYSTEM SPINAL/EPID.\n\n4. SESK ST. JOHN'S MERCY MED CTR SPINAL/EPID.\n\n5. SESK MAIMONIDES HOSPITAL SPINAL/EPIDURAL.\n\n6. SESK OU MEDICAL CENTER - SPINAL/EPIDURAL.\n\n7. SESK ELLIS HOSPITAL - SPINAL EPIDURAL.\n\n8. STONY BROOK HSP SPINAL EPIDRAL TRAY SESK. \n\n9. SESK UAB SPINAL EPIDURAL.\n\n10. SESK CREIGHTON UNIV BMH SOINAL EPIDURAL.\n\n11. SESK, BSW SPINAL EPIDURAL TRAY. \n\n12. LYNDON B JOHNSON HOSPITAL SPINAL EPID.", "code_info": "1. REF: 530029; Product Code: SESK; UDI-DI (Primary): 04046964305245; UDI-DI (Unit of Use): 04046964305238; Lot Number: 0062012031.\n\n2. REF: 530048; Product Code: SESK; UDI-DI (Primary): 04046964305313; UDI-DI (Unit of Use): 04046964305306; Lot Number: 0062006298.\n\n3. REF: 530155; Product Code: SESK; UDI-DI (Primary): 04046964306211; UDI-DI (Unit of Use): 04046964306204; Lot Number: 0062012054.\n\n4. REF: 530159; Product Code: SESK; UDI-DI (Primary): 04046964669286; UDI-DI (Unit of Use): 04046964669279; Lot Number: 0062012025.\n\n5. REF: 530169; Product Code: SESK; UDI-DI (Primary): 04046964808920; UDI-DI (Unit of Use): 04046964808913; Lot Number: 0062012035.\n\n6. REF: 530171; Product Code: SESK; UDI-DI (Primary): 04046964950391; UDI-DI (Unit of Use): 04046964950384; Lot Number: 0062006303.\n\n7. REF: 530180; Product Code: SESK; UDI-DI (Primary): 04046955156443; UDI-DI (Unit of Use): 04046955156436; Lot Number: 0062000738.\n\n8. REF: 530197; Product Code: SESK; UDI-DI (Primary): 04046955619337; UDI-DI (Unit of Use): 04046955619320; Lot Number: 0062003710.\n\n9. REF: 530194; Product Code: SESK; UDI-DI (Primary): 4046955589388; UDI-DI (Unit of Use): 4046955589371; Lot Number: 0062014360.\n\n10. REF: 530199; Product Code: SESK; UDI-DI (Primary): 04046955619375; UDI-DI (Unit of Use): 04046955619368; Lot Number: 0062001876.\n\n11. REF: 530160; Product Code: SESK; UDI-DI (Primary): 04046964813993; UDI-DI (Unit of Use): 04046964813986; Lot Number: 0062011011. \n\n12. REF: 530184; Product Code: SESK; UDI-DI (Primary): 04046955156528; UDI-DI (Unit of Use): 04046955156511; Lot Number: 0062003228. \n\nExpiration Date: 07/31/2026.", "firm_fei_number": "3013764800", "recalling_firm": "B BRAUN MEDICAL INC", "address_1": "861 Marcon Blvd", "city": "Allentown", "state": "PA", "postal_code": "18109-9577", "additional_info_contact": "Allison Longenhagen\n001-484-2408373", "reason_for_recall": "Potential for the lid of the catheter connector to be in the incorrect position.", "root_cause_description": "Process control", "action": "B Braun notified consignees on about 09/18/2025 via USPS certified mailed URGENT MEDICAL DEVICE CORRECTION NOTIFICATION. Consignees were instructed to, where possible, have a second kit or additional catheter connector available at the point of use and upon opening the kit, verify the correct catheter connector is present. If the affected component is detected, discard and do not use. Consignees were also instructed to review the Medical Device Correction Notification and ensure all users in your organization and other concerned persons are informed, if affected units have been further distributed, notify customers, post the notification where affected units are stored, and complete and return the \"Urgent Medical Device Correction Acknowledgement Form.\" Additionally, if consignees have identified affected units in inventory, they may order one case (50 pieces) of affected sterilized single use catheter connectors to have on hand.", "product_quantity": "2,450 units", "distribution_pattern": "Nationwide distribution to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV.", "openfda": { "registration_number": [ "2029015", "3005595283", "3006450239", "9616088", "3045816907", "3005012805", "3013162291", "1928237", "3035642068", "1423537", "3045816902", "3004076349", "1018470", "2523676", "1061124", "3006425876", "3008552585", "3015859709", "2521402", "3004122598", "1061927", "8022210", "1319639", "2433012", "1030451", "3007329020", "3004111573", "3010321647", "3013764800", "1423395", "9611612", "9680794", "3009888344", "1047429", "1643817", "3015173212" ], "fei_number": [ "3005595283", "1000512168", "3006450239", "3045816907", "3005012805", "3013162291", "1928237", "1000138054", "3035642068", "3045816902", "3004076349", "1018470", "2523676", "3006425876", "3008552585", "3015859709", "2521402", "3932", "3004122598", "3002807847", "3000203000", "3001236905", "3002902735", "2433012", "1030451", "3007329020", "1000160458", "3004111573", "3010321647", "3013764800", "3000717925", "3009888344", "1047429", "1643817", "3003737899", "3015173212" ], "device_name": "Epidural Anesthesia Kit", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5120", "device_class": "2" } } ] }