CareFusion Alaris Syringe Module, Model 8110
Reported: March 11, 2020 Initiated: February 4, 2020 #Z-1361-2020
Product Description
CareFusion Alaris Syringe Module, Model 8110
Reason for Recall
1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders
Details
- Recalling Firm
- CareFusion 303, Inc.
- Units Affected
- 114835
- Distribution
- Worldwide Distribution: (U.S. Nationwide) to states of: CO, SC, NY, CA, LA, TX, AK, ID, VA, DE, FL, PA, KY, KS, TN, WA, MS, IL, GA, AR, NC, NV, NE, OR, RI, WI, HI, GU, PR, MA, IA, CT, MI, AZ, ME, MT, IN, OH, WV, WY, MN, AL, NH, OK, DC, NJ, MO, SD, UT, NM, MD, VT, MP, ND, AS; and countries of: Canada, Australia, New Zealand, the Middle East, South Africa, Taiwan, Southeast Asia and the European Union.
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
CareFusion Alaris Syringe Module, Model 8110. Recalled by CareFusion 303, Inc.. Units affected: 114835.
Why was this product recalled? ▼
1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 11, 2020. Severity: Critical. Recall number: Z-1361-2020.
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