Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4

FDA device recall Z-2017-2025 · posted 2025-06-24 · Open, Classified

Recall details

Recalling firm

CareFusion 303, Inc.

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.

Action taken

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

Root cause

Software Design Change

Status

Open, Classified

Product code

BRY

Quantity affected

6,332

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

Date initiated

2025-05-08

Date posted

2025-06-24

Location

San Diego, CA