Recall Z-2094-2023 ยท BRY Cabinet, Table And Tray, Anesthesia
CareFusion 303, Inc.
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
| Date | Jul 5, 2023 (initiated May 22, 2023) |
| Status | Open, Classified |
| Reason | 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 | Labeling design |
| Action | 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 |
| Quantity | 9,906 |
| Distribution | 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, K |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.