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.
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