—#200708

Product

BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF: 107-223, 107-224, 111-191, 111-192, 111-193, 111-194, 111-195, 111-196, 111-197, 111-198; BD Pyxis CII Safe, Software: V8, 111-199-01, 111-200-01, 111-201-01, 111-202-01, 111-203-01, 111-204-01, 111-205-01, 111-206-01, 107-245-01, 107-246-01; BD Pyxis CII Safe, Software: V9, REF: 107-252-01, 111-215, 111-216, 111-219, 111-221. BD Pyxis CII Safe, Software: ES, REF: 107-254-01, 107-255-01, 1116-00, 1117-00; BD Pyxis CII Safe, Software: N/A, REF: 111-113, 111-114, 111-115, 111-160-201, 111-217, 111-218, 111-220, 111-222; Tripp Lite SUPER6TEL Surge Suppressor, REF: CN 200-025. Used with BD Pyxis CII Safe System: v7.x for WES7 User Guide, DIR 10000145747/ v8.1 User Guide, DIR 10000277635/v9.0 User Guide, DIR 10000354270/ ES User Guide v1.8, DIR 10000418517

FDA product code: BRY — Cabinet, Table And Tray, Anesthesia
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: UDI-DI: 10885403512520; Devices Manufactured May 04, 2006 - September 26, 2023

Why it was recalled

Automated dispensing cabinet devices plugged into any multi-socket outlet power strips may present unacceptable levels of current leakage, which could expose users to system downtime and/or potential electric shock.

Root cause (FDA determination)

Labeling design

Action the firm took

On 5/22/23, correction notices were sent to distributors, directors of pharmacy/biomedical engineering/risk management who were asked to take the following actions: 1) Always select an unused, hospital grade AC outlet for the connection. Do not use an extension cord or a multiple-socket outlet strip between the BD Pyxis CII Safe equipment power cord and wall outlet. 2) If the affected device is currently plugged into a multiple socket outlet, follow the shutdown instructions below: a) On the Main Menu screen, tap Exit. b) On the Windows taskbar, tap Start > Shut Down. c) Select Shut down and tap OK. d) After the station has shut down completely, move the power switch to the off position. e) Disconnect the power cord 3) Disseminate the correction notice within your facility network to ensure they are aware of the risks. 4) Complete and return the response form to BDRC43@bd.com 5) Customers with questions can call 1.800.727.6102 or 1.858.617.2000. Emails can also be sent to: Customer Self Service Portal: https://service.carefusion.com and productcomplaints@bd.com In addition, distributors were asked to identify all customers within their distribution network that purchased any affected product as defined in the notification. Provide a copy of the included customer letter to all customers to advise them of the field action notification on BD s behalf. On 10/31/23, amended correction notices were distributed informing additional customers of additional affected devices. In addition, customers were asked not use any MSO with BD Pyxis CIISafe devices or CIISafe accessories. If affected devices are plugged into multiple socket outlets, the firm is asking the customer to now create a case using the customer Self Service Portal, or contact BD Customer Support, 1.866.583.8783 8AM-5PM CST, to schedule a controlled shutdown of the device.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide-Worldwide Distribution: CO, MS, HI, FL, GA, CA, ND, GU, DE, MO, DC, SC, VA, AK, TX, NY, MN, PA, MA, OH, WI, NC, KY, KS, IL, MD, NE, MI, IA, WA, NM, LA, OK, AZ, AR, IN, WY, AL, NJ, SD, NV, TN, OR, WV, ME, ID, CT, UT, RI, MT, PR, NH, VT, AS OUS: GU, KW, AE, SA, NZ, CA, BE ,GB, IT, JP, KR, DE, AU, SG, BH, JO, QA, ES, AT, NL, OM, BM, AT

Timeline

Recall initiated: 2023-05-22
Posted by FDA: 2023-07-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #200708. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.