CareFusion 303, Inc. recalls BD Pyxis CII Safe ES, REF: 1116-00

Recall date

November 14, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0672-2025

FDA classification

Class II

Brand / firm

CareFusion 303, Inc.

Sold / distributed

Worldwide - US Nationwide distribution including in the states of OK, LA, FL, AR, VA, KY, PA, AL, NC, CA, MN, AK, TX, MI, ME, OH, OR, NY, IL, RI, GA, WI, NH, KS, CO, WA, MO, MD, AZ, SC, NV, WV, NM, IN, NJ, TN, DE, MT, MA, VT, DC, NE, CT, ID, WY, MS, UT, HI, IA, SD, ND, GU, MP, PR and the countries…

Why it was recalled

Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BD Pyxis CII Safe ES, REF: 1116-00