FDA-Device2020-08-12Class I
Alaris System PC Unit Model 8015. modular infusion pump and monitoring system
CareFusion 303, Inc.
Hazard
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.
Sold states
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
Affected count
824277
Manufactured in
10020 Pacific Mesa Blvd, San Diego, CA, United States
Products
Alaris System PC Unit Model 8015. modular infusion pump and monitoring system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2741-2020Don't want to check this manually?
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