{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216115", "product_res_number": "Z-0126-2026", "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, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product Descriptions: \n\n1.\tCESK ROBERT WOOD JOHNSON UNIV HOSP. \n\n2.\tCESK EAST JEFFERSON GEN HOSP 20071769. \n\n3.\tCESK FLETCHER ALLEN HOSPITAL. \n\n4.\tCESK WASHOE MEDICAL CENTER. \n\n5.\tCESK DETROIT MEDICAL CTR 20064586. \n\n6.\tCESK ALBANY MEDICAL CENTER. \n\n7.\tCESK EPIDURAL BLOCK TRAY. \n\n8.\tCESK, BSW EPIDURAL TRAY. \n\n9.\tCESK HOWARD COUNTY GENERAL. \n\n10.\tCESK CE17TKFC10L. \n\n11.\tCESK WILLIAMSON MEDICAL CENTER. \n\n12.\tCESK FLORIDA HOSPITAL. \n\n13.\tCESK RIVERSIDE HEALTH SYSTEM. \n\n14.\tCESK MAYO CLINIC OB. \n\n15.\tCESK PRESBYTERIAN HOSPITAL DALLAS. \n\n16.\tCESK HOUSTON METHODIST HOSPITAL. \n\n17.\tCESK OHIO STATE UNIV MEDICAL CENTER. \n\n18.\tCESK NORTONS WOMEN'S AND CHILDREN'S. \n\n19.\tCESK BEN TAUB. \n\n20.\tCESK PENN MEDICINE CONTINUOUS-ORIG CUST. \n\n21.\tCESK ALLEGHENY GENERAL HOSPITAL. \n\n22.\tCESK UNIVERSITY OF ILLINOIS MED CTR. \n\n23.\tCESK RUSH UNIVERSITY MEDICAL CENTER. \n\n24.\tCESK ST. JOSEPH MEDICAL CENTER. \n\n25.\tCESK INTEGRIS HEALTH. \n\n26.\tCESK UMASS MEMORIAL. \n\n27.\tCESK STANFORD UNIV HOSP 20054718. \n\n28.\tCESK OVERLAKE HOSPITAL. \n\n29.\tCESK CHRIST HOSPITAL 20057985. \n\n30.\tCESK NEWTON-WELLESLEY HOSPITAL.", "code_info": "1.\tREF: 551028; Product Code: CESK; UDI-DI (Primary): 04046964306334; UDI-DI (Unit of Use): 04046964306327; Lot Number: 0062017630.\n\n2.\tREF: 551474; Product Code: CESK; UDI-DI (Primary): 04046964306938; UDI-DI (Unit of Use): 04046964306921; Lot Number: 0062006292.\n\n3.\tREF: 551630; Product Code: CESK; UDI-DI (Primary): 04046964307560; UDI-DI (Unit of Use): 04046964307546; Lot Number: 0062017605.\n\n4.\tREF: 551749: Product Code: CESK; UDI-DI (Primary): 04046964307942; UDI-DI (Unit of Use): 04046964307935; Lot Number: 0062017615. \n\n5.\tREF: 551769: Product Code: CESK; UDI-DI (Primary): 04046964308024; UDI-DI (Unit of Use): 04046964308017; Lot Number: 0062006304. \n\n6.\tREF: 551998: Product Code: CESK; UDI-DI (Primary): 04046964310942; UDI-DI (Unit of Use): 04046964310928; Lot Number: 0062014368. \n\n7.\tREF: 552006: Product Code: CESK; UDI-DI (Primary): 04046964311215; UDI-DI (Unit of Use): 04046964311192; Lot Number: 0062013265. \n\n8.\tREF: 552076: Product Code: CESK; UDI-DI (Primary): 04046964814013; UDI-DI (Unit of Use): 04046964814006; Lot Number: 0062003111. \n\n9.\tREF: 552113: Product Code: CESK; UDI-DI (Primary): 04046964950193; UDI-DI (Unit of Use): 04046964950186; Lot Number: 0062006384. \n\n10.\tREF: 552116: Product Code: CESK; UDI-DI (Primary): 04046964950254; UDI-DI (Unit of Use): 04046964950247; Lot Number: 0061994277. \n\n11.\tREF: 552119: Product Code: CESK; UDI-DI (Primary): 04046964989780; UDI-DI (Unit of Use): 04046964989773; Lot Number: 0062017951. \n\n12.\tREF: 552123: Product Code: CESK; UDI-DI (Primary): 04046955057788; UDI-DI (Unit of Use): 04046955057771; Lot Number: 0062003214. \n\n13.\tREF: 552126: Product Code: CESK; UDI-DI (Primary): 04046955056903; UDI-DI (Unit of Use): 04046955056897; Lot Number: 0061999998. \n\n14.\tREF: 552133: Product Code: CESK; UDI-DI (Primary): 04046955127801; UDI-DI (Unit of Use): 04046955127795; Lot Number: 0062012017. \n\n15.\tREF: 552135: Product Code: CESK; UDI-DI (Primary): 04046955127849; UDI-DI (Unit of Use): 04046955127832; Lot Number: 0062013246. \n\n16.\tREF: 552136: Product Code: CESK; UDI-DI (Primary): 04046955127863; UDI-DI (Unit of Use): 04046955127856; Lot Number: 0062003706. \n\n17.\tREF: 552147: Product Code: CESK; UDI-DI (Primary): 04046955184071; UDI-DI (Unit of Use): 04046955186402; Lot Number: 0062017607. \n\n18.\tREF: 552152: Product Code: CESK; UDI-DI (Primary): 04046955214419; UDI-DI (Unit of Use): 04046955264407; Lot Number: 0062006313. \n\n19.\tREF: 552153: Product Code: CESK; UDI-DI (Primary): 04046955214426; UDI-DI (Unit of Use): 04046955243037; Lot Number: 0062017625.\n \n20.\tREF: 552174: Product Code: CESK; UDI-DI (Primary): 04046955589449; UDI-DI (Unit of Use): 04046955589432; Lot Number: 0062006317. \n\n21.\tREF: 552176: Product Code: CESK; UDI-DI (Primary): 04046955589487; UDI-DI (Unit of Use): 04046955589470; Lot Number: 0061983245.\n\n22.\tREF: 552177: Product Code: CESK; UDI-DI (Primary): 04046955596102; UDI-DI (Unit of Use): 04046955596096; Lot Number: 0062014364. \n\n23.\tREF: 552179: Product Code: CESK; UDI-DI (Primary): 04046955596140; UDI-DI (Unit of Use): 04046955596133; Lot Number: 0062013260. \n\n24.\tREF: 552180: Product Code: CESK; UDI-DI (Primary): 04046955596164; UDI-DI (Unit of Use): 04046955596157; Lot Number: 0062000125. \n\n25.\tREF: 552192: Product Code: CESK; UDI-DI (Primary): 04046955701063; UDI-DI (Unit of Use): 04046955701056; Lot Number: 0062005198. \n\n26.\tREF: 552197: Product Code: CESK; UDI-DI (Primary): 04046955862498; UDI-DI (Unit of Use): 04046955862481; Lot Number: 0062017634. \n\n27.\tREF: 555098: Product Code: CESK; UDI-DI (Primary): 04046964313578; UDI-DI (Unit of Use): 04046964313554; Lot Number: 0062006293. \n\n28.\tREF: 555422: Product Code: CESK; UDI-DI (Primary): 04046964315534; UDI-DI (Unit of Use): 04046964315503; Lot Number: 0062019003. \n\n29.\tREF: 555450: Product Code: CESK; UDI-DI (Primary): 04046964315831; UDI-DI (Unit of Use): 04046964315817; Lot Number: 0062016181. \n\n30.\tREF: 555484: Product Code: CESK; UDI-DI (Primary): 04046964315954; UDI-DI (Unit of Use): 04046964315930; Lot Number: 0062012043. \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": "5,770 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": [ "3015859709", "3005595283", "2029015", "3007329020", "1643817", "3009888344", "2433012", "1030451", "3004111573", "3045816907", "1047429", "1423537", "3013764800", "3004076349", "2523676", "3010321647", "3013162291", "1928237", "1423395", "9611612", "1319639", "3008552585", "9616088", "2521402", "3035642068", "8022210", "9680794", "1018470", "3005012805", "1061927", "3015173212", "1061124", "3006425876", "3004122598", "3045816902", "3006450239" ], "fei_number": [ "1000160458", "3000203000", "3015859709", "3000717925", "3005595283", "1000138054", "3002902735", "3001236905", "3007329020", "1643817", "3009888344", "2433012", "1030451", "3004111573", "3045816907", "1047429", "3013764800", "3004076349", "2523676", "3010321647", "3932", "3013162291", "1928237", "3008552585", "2521402", "3035642068", "3003737899", "1000512168", "1018470", "3005012805", "3015173212", "3006425876", "3004122598", "3045816902", "3002807847", "3006450239" ], "device_name": "Epidural Anesthesia Kit", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5120", "device_class": "2" } } ] }