—#212311

Product

BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF: 1156-00, CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01, CII Safe ES Desktop PC, W-less SCNR, REF: 107-255-01, Used with Enterprise Server (ES), REF: 1115-00 with affected Enterprise Server software.

FDA product code: BRY — Cabinet, Table And Tray, Anesthesia
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: BD Pyxis Enterprise Server software versions: 1.7.4.128, 1.7.4.134, 1.7.4.136, 1.7.4.137, All 1.7.1, All 1.7.2, All 1.7.3. REF/UDI-DI: 327/10885403477836, 323/10885403512667, 352/10885403512674, 1116-00/10885403512605

Why it was recalled

Sync timeout may occur between the server and automated dispensing device, due to a server software error which may occur if syncing a large amount of data that takes excessive time, which may cause the dispensing devices to become disconnected from the ES server; dispensing devices will not receive updated information, which may lead to incorrect therapy, and delay in accessing medication.

Root cause (FDA determination)

Software design

Action the firm took

On 2/6/2025, correction notices were mailed to customers informing them of the following: 1) Firm will be contacting customers and distributors to schedule time to upgrade software to 1.7.4.138 or a later release. 2) Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached customer letter to all customers to advise them of this field action notification. 3) Complete and return the customer/distributor response form via email to BDRC8@bd.com Report complaints to firm via the North American Regional Complaint Center: Phone: 1-844-8BD-LIFE (1-844-823-5433) Say "Product Complaints" when prompted Mon-Fri 8:00am - 5:00pm CT Email: productcomplaints@bd.com Recall/Remediation Related Questions: 1-866-583-8783, 8:00am ET to 7:00pm ET), Monday - Friday. Product Complaints or Technical Support: 1-800-727-6102 Phone hours: 24 hours, 7 days a week Website: bd.com/self-service

Recalling firm

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

Distribution

Distribution pattern: Worldwide - US Nationwide distribution including in the states of KY, OH, NY, MO, NC, PA, FL, TN, CT, LA, MN, VA, MD, CA, TX, NE, IA, OK, MI, PR, SD, IN, ME, KS, IL, NM, WA, AR, HI, MS, GA, WY, WI, VT, AL, NV, NJ, DC, AZ, MT, AK, OR, CO, NH, MA, SC, ID, UT, ND and the countries of TW, CA, AE, MX, SG, AU, NZ, GB, CH, BH.

Timeline

Recall initiated: 2025-02-06
Posted by FDA: 2025-03-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #212311. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.