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Product Name [REF] recallZ-2017-2025 · CareFusion 303, Inc. · initiated May 8, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from CareFusion 303, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error preventing user access to the dispensing software application, which may lead to delay in access to medications/supplies, and delivery/replenishment of patient specific orders; which may lead to delay in patient care.

FDA root cause category: Software Design Change

What the company is doing

On 5/8/2025, correction notices were mailed and emailed to Customers informing them of the following: Firm has temporarily configured impacted devices to "disabled" mode so the device will not automatically apply validated patches intended to address security vulnerabilities or performance issues. Device keys can be used to manually access unavailable drawers and must be readily available and retrievable to constitute risk mitigation; medications can also be obtained from other unaffected dispensing devices or pharmacy. The Pyxis Anesthesia Station unlocks non-secure drawers upon user login, providing immediate access to medications. Non-secure drawers remain unlocked while the user is logged in. User guides include instructions on how to manually access medications in an emergency: BD Pyxis MedStation ES user guide DME 10000430667 version 00 (page 120), BD Pyxis Anesthesia Station ES user guide DME 10000430730 version 00 (page 84). Other potential mitigations: -Healthcare facility system administrators can grant permission to add temporary patients to select staff per user guide DME 10000430667 version 00 (page 25). -Critical override or temporary Non-RX mode can be configured for impacted profile devices per user guide DME 10000430667 version 00 (pages 74-75). -Refill reports can be generated at the device to identify items requiring replenishment if inventory information is not communicated to the server. Share the recall letter with all network facilities and post recall letter on/near affected products. Complete and return response form: [email protected] Firm will coordinate with customers to obtain a schedule to implement "Managed Mode". Firm contacts: North American Regional Complaint Center: 1-844-823-5433, [email protected]; BD Remediation Support: 1-866-583-8783; BD Technical Support: 1-800-727-6102 On 12/2/2025 updated correction notices including additional affected devices were mailed/emailed to customers

Recall details

Recall number
Z-2017-2025
Status
Open, Classified
Initiated by the company
May 8, 2025
Posted by the FDA
Jun 24, 2025
Recalling firm
CareFusion 303, Inc.
Quantity
6,332
Product code
BRY
Distribution
Worldwide - US Nationwide distribution including in the states of PR, DE, GU, MO, IA, IL, CA, MD, MA, VA, PA, NY, WA, NJ, AZ, CO, OH, FL, WI, TX, CT, LA, MI, WY, MN, AR, KY, OR, NM, TN, NC, SC, IN, VT, KS, AL, GA, WV, NV, ID, DC, MS, NE, HI, OK, UT, ND, MT, NH, SD, ME, RI, AK, MP and the countries of SA, CA, NZ , CH, FR, IT, BE, AU, BH, QA, AE, GB, EG, AR, JO, DE, BM, TH, LB, BR, IE, FI, MX, TW, ID, SG, BS, IN, MA, GF, ES, HK.

Product description

Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 10885403512629 [303], BD Pyxis MedStation ES Tower 10885403512674 [352], BD Pyxis Anesthesia Station ES 10885403477836 [327], BD Pyxis MedStation ES (Main) 10885403512667 [323], MD BD Pyxis SupplyStation V9 [317], Security Module [139698-01], BD Knowledge Portal for Medication Technologies [136607-01], STOCKSTN V10.X WRD/WL SCANNERS [132-53-02], PRS STOCKSTN V10.X WRD/WL SCANNERS [132-53-01], STOCKSTN V10.X WIRED SCANNER [132-52-02], PRS STOCKSTN V10.X WIRED SCANNER [132-52-01], BD Pyxis CII Safe ES Desktop PC [1156-00], BD Pyxis SupplyStation Panel PC V11 [1132-00], BD Pyxis SupplyRoller V11 [1127-00], Dell 640 Server [1128-00], BD Pyxis SupplyStation System V11 [1123-00], BD Pyxis CII Safe ES 10885403512605 [1116-00], BD Pyxis Enterprise Server 10885403518348, 10885403520341 [1115-00], BD Pyxis SupplyRoller V10 [1101-00], BD Pyxis CIISafe V9.X SGL IM BIO 10885403512520 [111-221], BD Pyxis CIISafe V7.X DBL INTG MAIN BIO, SOLID DO [111-194], BD Pyxis CIISafe V8.X Desktop PC, Bio [107-245-01], BD Pyxis SupplyStation V10 [347], BD Pyxis CII Safe V9.X DESKTOP PC [107-252-01], BD Pyxis CII Safe V7.X DBL INTG MAIN BIO CLEAR DO [111-191], BD Pyxis CII Safe V7.XSGL INTG MAIN BIO SOLID DO [111-198], BD Pyxis CII SafeV8.XDBL INTG MAIN BIO SOLID DO [111-202-01], BD Pyxis CII SafeV8.XSGL INTG MAIN BIO SOLID DO [111-206-01], BD Pyxis CII Safe V9.X DBL IM BIO SLD DOORS [111-215], BD Pyxis CII Safe V9.X SGL IM BIO CLR DOORS [111-216], BD Pyxis CII Safe V9.X DBL IM BIO CLR DOORS [111-219], Supply itParActive RF V11 (Supply Kanban) [138566-01]

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Each customer was provided a unique list of their affected devices that included computer names and atlas keys. Distributed: April 14, 2014 - March 21, 2025 REF or Name [UDI-DI]: Supply Server [N/A], CCE Enterprise SW Site License (2-5) [N/A], 806 [N/A], 303 [10885403512629], 352 [10885403512674], 327 [10885403477836], 323 [10885403512667], 317 [N/A], 139698-01 [N/A], 136607-01 [N/A], 132-53-02 [N/A], 132-53-01 [N/A], 132-52-02 [N/A], 132-52-01[N/A] , 1156-00 [N/A], 1132-00 [N/A], 1127-0 [N/A], 1128-00 [N/A], 1123-00 [N/A], 1116-00 [N/A], 1115-00 [10885403518348, 10885403520341], 1101-00 [N/A], 111-221 [10885403512520], 111-194 [N/A], 107-245-01 [N/A], 347[N/A], 107-252-01 [N/A], 111-191 [N/A], 111-198 [N/A], 111-202-01 [N/A], 111-206-01 [N/A], 111-215 [10885403512520], 111-216 [10885403512520], 111-219 [10885403512520], 138566-01 [N/A]

Devices named in this recall

6 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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