—#211732

Product

BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352

FDA product code: BRY — Cabinet, Table And Tray, Anesthesia
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: Software v1.7.3. REF/UDI-DI: 323/10885403512667, 352/10885403512674

Why it was recalled

Due to an automated dispensing cabinet software issue, when a medication single order contains more than one component and at least one is unavailable for a multi-item or combination order, the order may display as grayed out; alternate location tooltip will display "Server connection failed," not listing other area devices where unavailable item(s) may be found, which may lead to delayed therapy.

Root cause (FDA determination)

Software design

Action the firm took

On 4/5/2023, correction notices were sent to customers who were asked to do the following: A permission-based feature called "Global Find" can be used to obtain alternate storage locations of medication(s) not loaded (by pharmacy) or depleted at that device and is not impacted by this issue. 1) Review and confirm that backup procedures (which may include but may not necessarily be limited to keys, emergency medication supplies, alternate devices in proximity, etc.) are in place and staff have all been properly trained on them to avoid delays in access to medications. 2) Ensure this letter is forwarded to applicable facilities if devices have been transferred and that all appropriate personnel have been made aware of this issue. 3) Complete and return the enclosed Customer Response Form via email to BDRC23@bd.com 4) Adverse health consequences experienced with the use of this product should be reported to BD at 1-800-727-6102 or via bd.com/self-service. Recall/Letter Questions: BD Customer Support, Phone: 1-866-583-8783, Phone Hours: 5:00am PST to 4:00pm PST (8:00am ET to 7:00pm ET), Monday - Friday A software update is available. BD will contact you to schedule a time to install the software update.

Recalling firm

Firm: CareFusion 303, Inc.
Address: 10020 Pacific Mesa Blvd, San Diego, California 92121-4386

Distribution

Distribution pattern: US Nationwide distribution in the states of NY, NC, LA.

Timeline

Recall initiated: 2023-04-05
Posted by FDA: 2025-01-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #211732. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.