{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "214411",
      "product_res_number": "Z-2453-2025",
      "event_date_initiated": "2025-06-16",
      "event_date_posted": "2025-08-27",
      "recall_status": "Open, Classified",
      "res_event_number": "97070",
      "product_code": "ONB",
      "k_numbers": [
        "K123213",
        "K130197",
        "K140591",
        "K181221",
        "K201099"
      ],
      "product_description": "BD PhaSeal Injector Luer (N30C), REF: 515001\nBD PhaSeal Injector Luer Lock (N35), REF: 515003\nBD PhaSeal Injector Luer Lock (N35C), REF: 515004\nBD PhaSeal Injector Lu63er Lock (N35C Multi), REF: 515005\nBD PhaSeal Protector (P14), REF: 515100\nBD PhaSeal Protector (P21), REF: 515102\nBD PhaSeal Protector (P21 Multi), REF: 515103\nBD PhaSeal Protector (P28), REF: 515104\nBD PhaSeal Protector (P50), REF: 515105\nBD PhaSeal Protector (P50 Multi), REF: 515106\nBD PhaSeal Protector (P53), REF: 515107\nBD PhaSeal Protector (P55), REF: 515117\nBD PhaSeal Connector Luer Lock (C35), REF: 515200\nBD PhaSeal Connector Luer Lock (C45), REF: 515202\nBD PhaSeal Y-site Connector (C80), REF: 515304\nBD PhaSeal L Connector (C90), REF: 515305\nBD PhaSeal Infusion Adapter (C100), REF: 515306\nBD PhaSeal Infusion Adapter (C100 Multi), REF: 515307\nBD PhaSeal Cap for Injector (M50), REF: 515404\nBD PhaSeal Connector Cap (M70), REF: 515406\nBD PhaSeal Optima Injector (N35-O), REF: 515052\nBD PhaSeal Optima Injector (N35-O Multi), REF: 515053\nBD PhaSeal Injector Locking (N40-O), REF: 515056\nBD PhaSeal Injector Locking (N40-O Multi), REF: 515057\nBD PhaSeal Optima Protector (P13-O), REF: 515060\nBD PhaSeal Optima Protector (P13-O Multi), REF: 515062\nBD PhaSeal Optima Protector (P28-O), REF: 515063\nBD PhaSeal Optima Protector (P20-O), REF: 515064\nBD PhaSeal Optima Protector (P20-O Multi), REF: 515065\nBD PhaSeal Optima Connector (C35-O), REF: 515070\nBD PhaSeal Optima Infusion Adapter (C100-O), 515078\nBD PhaSeal Optima Infusion Adapter (C100-O Multi), REF: 515079",
      "code_info": "REF/UDI-DI/Lot(Expiration):\n515001/00382905150012.\n515003/00382905150036/2402001(31-Jul-26), 2403002(31-Aug-26), 2403003(31-Aug-26), 2404006(30-Sep-26), 2405007(31-Oct-26), 2405014(31-Oct-26), 2408005(31-Jan-27), 2408006(31-Jan-27), 2409005(28-Feb-27), 2403713(31-Aug-26), 2404001(30-Sep-26), 2404002(30-Sep-26), 2404003(30-Sep-26), 2404004(30-Sep-26), 2404005(30-Sep-26), 2410001(31-Mar-27), 2410002(31-Mar-27), 2411001(30-Apr-27), 2411002(30-Apr-27), 2411003(30-Apr-27), 2411709(30-Apr-27), 2412002(31-May-27), 2501001(30-Jun-27), 2501002(30-Jun-27), 2501003(30-Jun-27), 2502001(31-Jul-27), 2502002(31-Jul-27), 2405004(31-Oct-26), 2405008(31-Oct-26), 2407001(31-Dec-26), 2412001(31-May-27), 2503001(31-Aug-27), 2503002(31-Aug-27), 2503003(31-Aug-27), 2504001(30-Sep-27), 2504002(30-Sep-27), 2504003(30-Sep-27);\n\n515004/00382905150043/2405001(31-Oct-26), 2408018(31-Jan-27), 2411708(30-Apr-27), 2411727(30-Apr-27);\n\n515005/00382905150050/2403006(31-Aug-26), 2404008(30-Sep-26), 2404009(30-Sep-26), 2404010(30-Sep-26), 2404011(30-Sep-26), 2404012(30-Sep-26), 2405002(31-Oct-26), 2407010(31-Dec-26), 2409011(28-Feb-27), 2409012(28-Feb-27), 2409016(28-Feb-27), 2410007(31-Mar-27), 2410008(31-Mar-27), 2410010(31-Mar-27), 2411725(30-Apr-27), 2405003(31-Oct-26), 2407011(31-Dec-26), 2407012(31-Dec-26), 2408008(31-Jan-27), 2408009(31-Jan-27), 2409007(28-Feb-27), 2409008(28-Feb-27), 2409009(28-Feb-27), 2409010(28-Feb-27), 2501006(30-Jun-27), 2503738(31-Aug-27), 2504004(30-Sep-27);\n\n515100/00382905151002/2504117(31-Mar-30), 2404103(31-Mar-29), 2404122(31-Mar-29), 2404123(31-Mar-29), 2406112(31-May-29), 2406113(31-May-29), 2404124(31-Mar-29), 2405130(30-Apr-29), 2407112(30-Jun-29), 2409113(31-Aug-29), 2410113(30-Sep-29), 2410114(30-Sep-29), 2411115(31-Oct-29), 2412109(30-Nov-29), 2502116(31-Jan-30), 2503112(28-Feb-30);\n\n515102/00382905151026/2403101(28-Feb-29), 2403102(28-Feb-29), 2403103(28-Feb-29), 2403104(28-Feb-29), 2403141(28-Feb-29), 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2410202(30-Sep-28), 2411201(31-Oct-28), 2411203(31-Oct-28), 2501202(31-Dec-28), 2502201(31-Jan-29), 2503201(28-Feb-29), 2503202(28-Feb-29), 2504201(31-Mar-29), 2504202(31-Mar-29).\n\n515202/00382905152023/2404207(31-Mar-28), 2404202(31-Mar-28), 2407201(30-Jun-28), 2412202(30-Nov-28), 2501222(31-Dec-28), 2503206(28-Feb-29), 2504203(31-Mar-29).\n\n515304/00382905153044/2406206(30-Sep-26), 2412212(31-Jan-27), 2503802(30-Apr-27).\n\n515305/00382905153051/2403220(29-Feb-28), 2405221(30-Apr-28), 2405222(30-Apr-28), 2409218(31-Aug-28), 2404201(31-Mar-28), 2404206(31-Mar-28), 2502215(31-Jan-29).\n\n515306/00382905153068/2402228(31-Jan-29), 2404210(31-Mar-28), 2404211(31-Mar-28), 2404212(31-Mar-28), 2404213(31-Mar-28), 2404214(31-Mar-28), 2404215(31-Mar-28), 2404216(31-Mar-28), 2406204(31-May-28), 2410212(30-Sep-28), 2410213(30-Sep-28), 2412216(30-Nov-28), 2404209(31-Mar-28), 2405224(30-Apr-28), 2502213(31-Jan-29), 2502214(31-Jan-29), 2406202(31-May-28), 2406203(31-May-28), 2410217(30-Sep-28), 2411206(31-Oct-28), 2411207(31-Oct-28), 2411721(31-Oct-28), 2411722(31-Oct-28), 2411723(31-Oct-28), 2412205(30-Nov-28), 2412206(30-Nov-28), 2412217(30-Nov-28), 2501213(31-Dec-28), 2501214(31-Dec-28), 2503207(28-Feb-29), 2503208(28-Feb-29), 2503209(28-Feb-29), 2504204(31-Mar-29), 2504205(31-Mar-29), 2504206(31-Mar-29).\n\n515307/00382905153075 2403714(29-Feb-28), 2502212(31-Jan-29), 2403601(28-Feb-26), 2405225(30-Apr-28), 2410216(30-Sep-28).\n\n515404/00382905154041/2404203(31-Mar-29), 2409220(31-Aug-29), 2405201(30-Apr-29), 2405202(30-Apr-29), 2406205(31-May-29).\n\n515406/00382905154065/2404217(31-Mar-29).\n515052/00382905150524/2403303(31-Aug-26), 2403304(31-Aug-26), 2403306(31-Aug-26), 2403307(31-Aug-26), 2404301(30-Sep-26), 2406303(30-Nov-26), 2406702(30-Nov-26), 2406801(30-Nov-26), 2408305(31-Jan-27), 2409302(28-Feb-27), 2410304(31-Mar-27), 2410306(31-Mar-27), 2411301(30-Apr-27), 2411302(30-Apr-27), 2412305(31-May-27), 2501303(30-Jun-27), 2501304(30-Jun-27), 2501305(30-Jun-27), 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2407306(31-Dec-26), 2407307(31-Dec-26), 2407308(31-Dec-26), 2407802(31-Dec-26), 2408309(31-Jan-27), 2408310(31-Jan-27), 2411303(30-Apr-27), 2501601(30-Jun-27), 2502701(31-Jul-27), 2502702(31-Jul-27), 2502703(31-Jul-27), 2502704(31-Jul-27), 2503723(31-Aug-27), 2503724(31-Aug-27), 2503725(31-Aug-27), 2504308(30-Sep-27).\n\n515056/00382905150562/2405306(31-Oct-26), 2405307(31-Oct-26), 2405308(31-Oct-26), 2405312(31-Oct-26), 2408301(31-Jan-27), 2406301(30-Nov-26), 2409310(28-Feb-27), 2410301(31-Mar-27), 2410303(31-Mar-27), 2411304(30-Apr-27), 2411305(30-Apr-27), 2412301(31-May-27), 2501306(30-Jun-27), 2501307(30-Jun-27), 2501308(30-Jun-27), 2502301(31-Jul-27), 2502302(31-Jul-27), 2407309(31-Dec-26), 2407310(31-Dec-26), 2408302(31-Jan-27), 2409309(28-Feb-27), 2410302(31-Mar-27), 2410309(31-Mar-27), 2411306(30-Apr-27), 2503736(31-Aug-27), 2503737(31-Aug-27), 2504301(30-Sep-27), 2504801(30-Sep-27).\n\n515057/00382905150579/2405311(31-Oct-26), 2409308(28-Feb-27), 2411308(30-Apr-27), 2412302(31-May-27), 2501309(30-Jun-27), 2501310(30-Jun-27), 2408303(31-Jan-27), 2411307(30-Apr-27), 2504302(30-Sep-27).\n\n515060/00382905150609/2403413(28-Feb-26), 2403415(28-Feb-26), 2404408(31-Mar-26), 2404409(31-Mar-26), 2405409(30-Apr-26), 2405410(30-Apr-26), 2405412(30-Apr-26), 2405413(30-Apr-26), 2405414(30-Apr-26), 2405415(30-Apr-26), 2406407(31-May-26), 2407805(30-Jun-26), 2407806(30-Jun-26), 2407807(30-Jun-26), 2403414(28-Feb-26), 2404407(31-Mar-26), 2404410(31-Mar-26), 2405411(30-Apr-26), 2407803(30-Jun-26), 2407804(30-Jun-26), 2408406(31-Jul-26), 2408407(31-Jul-26), 2408408(31-Jul-26), 2409411(31-Aug-26), 2409413(31-Aug-26), 2410402(30-Sep-26), 2410408(30-Sep-26), 2410409(30-Sep-26), 2410410(30-Sep-26), 2410416(30-Sep-26), 2410417(30-Sep-26), 2410602(30-Sep-26), 2411413(31-Oct-26), 2411414(31-Oct-26), 2412407(30-Nov-26), 2412408(30-Nov-26), 2412409(30-Nov-26), 2412410(30-Nov-26), 2412411(30-Nov-26), 2412701(30-Nov-26), 2501406(31-Dec-26), 2409412(31-Aug-26), 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      "firm_fei_number": "3012798826",
      "recalling_firm": "BD SWITZERLAND SARL",
      "address_1": "17 terre bonne park a4 route de crassier",
      "city": "Eysins",
      "country": "Switzerland",
      "reason_for_recall": "Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.",
      "root_cause_description": "Error in labeling",
      "action": "On 6/16/2025, Medical Device Product Advisory notices were mailed and emailed to customers who were asked to do the following:\n1) The US IFU to be attached to your product can be accessed and downloaded from the following link by searching under the applicable product code: The US IFU to be attached to your product can be accessed and downloaded from the following link by searching under the applicable product code: eIFU.bd.com\n2) Circulate this notice to all those who need to be aware within your organization or to any organization where the potentially affected products have been transferred.\n3) Complete the attached Customer Response Form and return via email to BDRC13@bd.com\n\nDistributors were asked to do the following: Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached customer letter to all customers to advise them of this product advisory on recalling firm's behalf.\n\nReport any complaints experienced with the use of this product to firm via the North American Regional Complaint Center:\nPhone: 1-844-823-5433 Say \"Product Complaints\" when prompted Mon-Fri 8:00am to 5:00pm CT, Email: productcomplaints@bd.com",
      "product_quantity": "3,884,670",
      "distribution_pattern": "US Nationwide distribution including in the states of CA, WA, AL, OH, NC, GA, MA, IL, MO, AZ, PA, MS, MN, MI, TX, VA, IN, NV, CO, FL, WV, WI, NY, NJ, UT, MD, MT, NM, TN, HI, OK, OR, AK, DC, IA, LA, ME, SC.",
      "openfda": {
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        "device_name": "Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5440",
        "device_class": "2"
      }
    }
  ]
}