FDA-Device2020-09-16Class I
BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652
CareFusion 303, Inc.
Hazard
The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in delays in infusion, under-infusion, or over-infusion.
Sold states
US - AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY OUS - AE, AU, BE, BH, CA, CH, CN, IN, KW, MX, MY, NL, NZ, PH, QA, SA, TW and ZA
Affected count
180,186 parts & devices
Manufactured in
10020 Pacific Mesa Blvd, San Diego, CA, United States
Products
BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2882-2020Don't want to check this manually?
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