Medical device recalls Moderate risk

CareFusion 303, Inc. recalls Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system

Recall date
August 15, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3141-2024
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 Syringe Module Model 8110, a modular infusion pump and monitoring system

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