| | Class 2 Device Recall BD Pyxis Products |  |
| Date Initiated by Firm | May 08, 2025 |
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| Date Posted | June 24, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2017-2025 |
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| Recall Event ID |
96585 |
| Product Classification |
Cabinet, table and tray, anesthesia - Product Code BRY
|
| Product | 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] |
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| Code Information |
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] |
| FEI Number |
2016493
|
Recalling Firm/
Manufacturer |
CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
|
Manufacturer Reason
for Recall | 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. |
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FDA Determined
Cause 2 | Software Design Change |
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| Action | 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: BDRC22@bd.com
Firm will coordinate with customers to obtain a schedule to implement "Managed Mode".
Firm contacts: North American Regional Complaint Center: 1-844-823-5433, productcomplaints@bd.com; 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
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| Quantity in Commerce | 6,332 |
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| 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.
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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