Recall Z-2740-2020 ยท FRN Pump, Infusion
CareFusion 303, Inc.
Alaris System PC Unit Model 8000 modular infusion pump and monitoring system
| Date | Aug 6, 2020 (initiated Jun 30, 2020) |
| Status | Terminated |
| Reason | If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on battery power, the system may experience a power loss with a prolonged, non-silenceable alarm. Power loss may result in an interruption of patient therapy or monitoring. |
| Root cause | Nonconforming Material/Component |
| Action | On 06/30/2020, Urgent Medical Device Recall Notifications were mailed to Directors of Biomedical Engineering, Nursing, Risk Management, Environmental Services. Actions for Clinical Users: This situation only occurs when the device is running on battery power. 1. If this issue occurs, immediately plug the PC unit into AC power and restart the infusions. 2. Obtain a replacement PC unit as soon as possible. 3. Ensure back-up devices are readily available when infusing critical medications. Please also ensure that you have back-up monitoring devices (e.g., EtCO2, SpO2) that are critically importa |
| Quantity | 37141 |
| Distribution | U.S.: CO, FL, SC, NY, CA, NC, TX, IL, PA, AZ, LA, IN, MA, MO, AR, WI, HI, OR, OH, KS, MN, MI, WA, UT, MD, TN, CO, NJ, NE, ND, WV, KY, IA, MS, AL, DE, AK, VA, OK, NM, GA, CT, SD, NV, ID, MT, ME, VT, WY, NH, MP, DC, GU, PR, AS, RI. O.U.S.: TR, QA, CA, AE, KW, MX, IL, SA, CH, NL, BE, TW, ZA, PH, CN, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133532 | ALARIS SYSTEM WITH GUARDRAILS SUITE MX Carefusion 303, Inc., Aug 21, 2014 |