CareFusion 303, Inc. recalls Alaris Pump Module Model 8100, a modular infusion pump and monitoring system

Recall date

August 15, 2024

Source

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

Recall number

Z-3142-2024

FDA classification

Class II

Brand / firm

CareFusion 303, Inc.

Sold / distributed

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

Why it was recalled

Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.

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

What was recalled

Alaris Pump Module Model 8100, a modular infusion pump and monitoring system