PlainRecalls
FDA Devices Critical Class I Ongoing

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

Reported: September 16, 2020 Initiated: August 4, 2020 #Z-2882-2020

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
CareFusion 303, Inc.
Units Affected
180,186 parts & devices
Distribution
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
Location
San Diego, CA

Frequently Asked Questions

What product was recalled?
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. Recalled by CareFusion 303, Inc.. Units affected: 180,186 parts & devices.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 16, 2020. Severity: Critical. Recall number: Z-2882-2020.