Recall Z-2882-2020 ยท FRN Pump, Infusion
CareFusion 303, Inc.
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
| Date | Sep 4, 2020 (initiated Aug 4, 2020) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | The recall letter was sent via FedEx, 2nd day air, on August 4, 2020. On December 16, 2022, CareFusion expanded the recall to include additional affected customers. The notification was mailed via FedEx, 2nd day Air. Action for Clinical Users: Ensure that the displayed syringe manufacturer and syringe size correctly identify the installed syringe. If the PC unit displays an incorrect syringe type and/or size, remove the device from service and send to Biomedical Engineering for repair. The biomedical engineer should: - Conduct a barrel clamp accuracy test as outlined in the "Preventi |
| Quantity | 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 |
| FDA record | Open on fda.gov |