CareFusion 303, Inc. Alaris System PC Unit Model 8000 modular infusion pump and monitoring system Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Alaris System PC Unit Model 8000 modular infusion pump and monitoring system
Brand
CareFusion 303, Inc.
Lot Codes / Batch Numbers
All serial numbers
Products Sold
All serial numbers
CareFusion 303, Inc. is recalling Alaris System PC Unit Model 8000 modular infusion pump and monitoring system due to 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,. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 important to the patient's care. 4. Complete and return the Customer Response Card. Actions for Cleaning Personnel: Inspect all PC unit batteries for missing screws and washers during cleaning. Should missing screws or washers be identified, send PC unit to Biomedical Engineering for repair. Expedite the inspection of all PC unit batteries for loose or missing screws and washers. If loose or missing screws and washers are identified, please replace them and torque any loose screws or washers to 6 in/lb and perform battery conditioning. See Service Bulletin 592A. Contact recalling firm at 1-800- 482-4822 to order a package of screws and washers. Battery should be replaced every two years by qualified service personnel using authorized batteries. Actions by Recalling Firm: Battery Pack Assembly procedure was revised to add clarity for reassembly of the battery, including proper use of screws and washers. Updated Service Bulletin to be provided in August 2020. An initial quantity of replacement screws and washers will be provided for use. Future orders for replacement batteries will include screws and washers System rental providers, please provide a copy of this letter and enclosures to your customers who are renting affected devices. Recall resources/customer support: www.bd.com/alaris-system-hardware-recall Questions - Recall Support Center: 858-617-1316, GMB-Ala
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC, PR
Page updated: Jan 10, 2026