PlainRecalls
FDA Devices Critical Class I Terminated

Alaris System PC Unit Model 8015. modular infusion pump and monitoring system

Reported: August 12, 2020 Initiated: June 30, 2020 #Z-2741-2020

Product Description

Alaris System PC Unit Model 8015. modular infusion pump and monitoring system

Reason for Recall

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.

Details

Recalling Firm
CareFusion 303, Inc.
Units Affected
824277
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, AU, IN, FR, MY, NZ, GB, KR, PK, DE, SG, JP, CU, BH
Location
San Diego, CA

Frequently Asked Questions

What product was recalled?
Alaris System PC Unit Model 8015. modular infusion pump and monitoring system. Recalled by CareFusion 303, Inc.. Units affected: 824277.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 12, 2020. Severity: Critical. Recall number: Z-2741-2020.