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Recall Observatory FDA recall evidence

Device product

Alaris System PC Unit Model 8015

Z-2909-2020

August 04, 2020

Class I

Product summary

Firm
CareFusion 303, Inc.
Event
Event 85900
Status
Ongoing
Classification
Class I
Quantity
313740
Official record key
device-enforcement:Z-2909-2020

Official wording

Reason: 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.

Code information: All serial numbers manufactured from April 07, 2017 to Present.

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.