FDA recall Z-0928-2023

CareFusion 303, Inc. · Class II · device

Product

BD Pyxis MedBank System - Product Label/labeling pending

Reason for recall

Due to customer complaints related to the MedBank software which may indicate that a different medication is loaded in a cubie (drawer) pocket than what is physically loaded and listed on the pocket label. As a result of this issue, a patient could receive the wrong medication or wrong dose of medication that could lead to patient harm.

Distribution

U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV.

Key facts

Status
Ongoing
Initiation date
2022-12-12
Report date
2023-01-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0928-2023