FDA Device recall Z-2909-2020
Alaris System PC Unit Model 8015
- FDA Device
- Class I
- ongoing
- Published 2020-09-16
On 2020-09-16 the FDA classified a Class I recall of Alaris System PC Unit Model 8015 by Carefusion 303, citing 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 infu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2909-2020 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2020-08-04 |
| Published | 2020-09-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Carefusion 303 |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
Alaris System PC Unit Model 8015
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.
Identifiers
| code_info | All serial numbers manufactured from April 07, 2017 to Present. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2909-2020%22
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