Z-2909-2020 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 16, 2020
- Initiation Date
- August 4, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 313740
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.
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
Code Information
All serial numbers manufactured from April 07, 2017 to Present.