BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, R

FDA device recall Z-2374-2024 · posted 2024-07-17 · Open, Classified

Recall details

Recalling firm

CareFusion 303, Inc.

Reason for recall

If automated dispensing cabinets have specific software versions, and Component Manager was configured to "installed mode", and software patch KB 5033688 was installed in the production environment, then this will will lead to an error that prevents the user from accessing the dispensing software application, which may delay accessing medication.

Action taken

On 6/6/24, correction notices were distributed to customers who were informed that their devices had been remediated. That they had been contacted by phone in May 2024 to schedule device remediation. The firm re-configured the component manager from "installed mode" to "disabled mode" and checked if the Microsoft patch was present on each device. If the patch was identified on a device, it was removed. All devices were then configured to "managed mode" and rebooted to enable the system appropriately. Customers are asked to complete and return the response form to Email BDRC15@bd.com For safety information about the system not covered in this document, call the firm's Technical Support Center at 1-800-727-6102, Phone hours: 24 hours, 7 days a week. Additional contacts include: 1) Regional Complaint Center, 1-844-823-5433 Say "Product Complaints" when prompted Mon-Fri 8:00am and 5:00pm CT, Email: productcomplaints@bd.com 2) Post Market Quality Field Action Operations, BDRC15@bd.com

Root cause

Software change control

Status

Open, Classified

Product code

BRY

Quantity affected

326

Distribution

Worldwide - US Nationwide distribution including in the states of OR, KS, NE, LA, ND, OK, AL, AK, WI, WV, WA, NV, PR, TX, CO, OH, CA, MO, IA, AZ, IN, AR, IL, MN, HI, NM, FL, SD, UT, NY, VA, GA, MA, NC

Date initiated

2024-05-02

Date posted

2024-07-17

Location

San Diego, CA