FDA-Device2024-09-25Class II
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
CareFusion 303, Inc.
Hazard
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.
Sold states
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 countries of United Arab Emirates, Australia, Belgium, Canada, Hungary, Kuwait, Qatar, Saudi Arabia, Singapore, Taiwan, and New Zealand.
Affected count
10460
Manufactured in
10020 Pacific Mesa Blvd, San Diego, CA, United States
Products
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3139-2024Don't want to check this manually?
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