Recall Z-2262-2024 ยท FRN Pump, Infusion
CareFusion 303, Inc.
BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
| Date | Jul 3, 2024 (initiated May 21, 2024) |
| Status | Open, Classified |
| Reason | Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server. |
| Root cause | Under Investigation by firm |
| Action | On August 22, 2024 a subsidiary of Becton, Dickinson and Company (BD) issued a second "Urgent Medical Device Correction" notification via FedEx and E-Mail to new consignees as well as consignees that previously received the 1st recall notification on June 3, 2024. BD asked consignees to take the following actions: 1. If the PCU is connected to the Server, no further actions are necessary, and PCU will function as intended. 2. If the PCU loses connection to the Server, the wireless network indicator icon on the PCU will be in an OFF state (not illuminated), and the PCU can continue to be used |
| Quantity | 168 software version |
| Distribution | US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211218 | BD Alaris System with Guardrails Suite MX v12.1.2 Carefusion 303, Inc., Jul 21, 2023 |