FDA recall Z-2255-2024

CareFusion 303, Inc. · Class II · device

Product

BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/ 169-101, MEDBANK MINI 1HH-1HM-1FM/ 169-102, MEDBANK MINI 1HH-3HM/ 169-103, MEDBANK MINI 2FH/ 169-104, MEDBANK MINI 2FM/ 169-105, MEDBANK MINI 2HH-1FH/ 169-106, MEDBANK MINI 2HH-1FM/ 169-107, MEDBANK MINI 2HH-1FM MEDPASS/ 169-152, MEDBANK MINI 2HH-2HM/ 169-108, MEDBANK MINI 2HM-1FM/ 169-109, MEDBANK MINI 3HH-1FG/ 169-110, MEDBANK MINI 3HH-1HM/ 169-111, MEDBANK MINI 4HH/ 169-112, MEDBANK MINI 4HH MEDPASS/ 169-150, MEDBANK MINI 4HM/ 169-113, MEDBANK MINI CR-2HH-1FH-P/ 169-114, MEDBANK MINI CR-4HH-P/ 169-115, MB MINI MAIN CR/ 169-163, MB MINI MAIN W/CUBIE DRWS/ 169-159, MB MINI MAIN W/FH FALSE DRW/ 169-162, MB MINI MAIN W/HH FALSE DRW/ 169-161, MB MINI MAIN W/MATRIX DRWS / 169-160, MB MINI MAIN W/MP/ 169-164 Used with the following user guides: BD Pyxis CUBIE Replenishment Station User Guide (DIR 10000414989), BD Pyxis MedBank Cabinet User Gui

Reason for recall

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.

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.

Key facts

Status
Ongoing
Initiation date
2024-05-13
Report date
2024-07-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2255-2024