Alaris System PC Unit Model 8015
Reported: September 16, 2020 Initiated: August 4, 2020 #Z-2909-2020
Product Description
Alaris System PC Unit Model 8015
Reason for Recall
The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, interruption of infusion, or inability to titrate medication. For high-risk patient populations who are receiving life-sustaining infusions, delays in an infusion or interruption can cause serious injury or death.
Details
- Recalling Firm
- CareFusion 303, Inc.
- Units Affected
- 313740
- Distribution
- U.S.:LA, FL, KY, MI, AL, GA, CA, TN, NC, TX, MA, OH, CO, WI, IL, KS, MO, UT, AK, MD, NY, NV, VA, NE, IN, PA, VT, DC, SC, CT, AR, NJ, MT, ND ,HI , NH, WA, DE, ME, OR, MN, AZ, MS, IA, NM, WY, ID, OK, SD, WV, MP, GU O.U.S.: CA, AE, AU, BE, CA, CH, IL, IN, KW, N/A, NL, NZ, PH, QA, SA, SG, TW, US, ZA
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
Alaris System PC Unit Model 8015. Recalled by CareFusion 303, Inc.. Units affected: 313740.
Why was this product recalled? ▼
The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, interruption of infusion, or inability to titrate medication. For high-risk patient populations who are receiving life-sustaining infusions, delays in an infusion or interruption can cause serious injury or death.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 16, 2020. Severity: Critical. Recall number: Z-2909-2020.
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