Recall Z-2256-2024 ยท BRY Cabinet, Table And Tray, Anesthesia
CareFusion 303, Inc.
BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 169-157, BD PYXIS MB TWR MN 1FM-10HH-1FH MP/ 169-143, BD PYXIS MB TWR MN 2FH-1FM-4HH-2FM MP/ 169-145, BD PYXIS MB TWR MN 2FM-8HH-1FH MP/ 169-144, BD PYXIS MB TWR MN 4FH-4HH-1FM MP/ 169-142, BD PYXIS MB TWR RXNOW MAIN W/MED PRINTER / 169-155, BD PYXIS MB TWR RXNOW MAIN W/PAT PRINTE
| Date | Jul 2, 2024 (initiated May 13, 2024) |
| Status | Open, Classified |
| Reason | Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical Commission (IEC) electrical standards when used as a system with automated dispensing cabinet devices, so use may expose user to leakage currents that could cause varying degrees of harm from a minor shock to permanent impairment. |
| Root cause | Component design/selection |
| Action | On 5/13/24, correction notices were mailed and emailed to customers informing them of the following: 1) Beginning, July 21, 2023, the firm ceased providing devices with MSO Power Strips and began providing devices with Uninterrupted Power Supply (UPS). 2) Firm will be providing impacted customers with UPS replacement devices for MSO Power Strips. Firm will be issuing a follow-up communication in the upcoming weeks with additional details regarding UPS replacement devices. 3) Firm will be updating user guides to clarify against the use of MSO Power Strips with affected devices. User guides can |
| Quantity | 3002 |
| Distribution | US Nationwide distribution including in the states of NY, CA, MO, AZ, CO, KS, IL, FL, OK, OH, TN, GA, NM, NV, NE, TX, NC, KY, WI, SC, IA, MT, SD, VA, NJ, PA, AK, MS, MI, WA, UT, ND, MA, MN, OR, IN, WV, AL, ID, LA, CT, WY, MD, NH, AR, HI, DC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.