Alaris Pump Module model 8100 manufactured between November 2011 and… — Class II medical device recall Z-0026-2018
Ongoing recall by CareFusion 303, Inc., reported 2017-10-25, distributed nationwide. The recalling firm has received reports of increased or decreased flows that have occurred in certain pumps.
| Recall number | Z-0026-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2017-08-09 |
| Classified | 2017-10-19 |
| Reported by FDA | 2017-10-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA, KW, SA, ZA |
| Quantity | 31,622 units |
| Serial numbers | 12340716, 12341830, 12344336, 12344631, 12356973, 12366930, 12367649, 12367659, 12367775, 12367815, 12368485, 12389182, 12389259, 12389723, 12389924, 12390048, 12390059, 12390063, 12390110, 12390952, 12392611, 12392763, 12421349, 12426401, 12430945 and 475 more |
| Model numbers | 8100 |
Product
Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using the IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.
Reason for recall
The recalling firm has received reports of increased or decreased flows that have occurred in certain pumps.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0026-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.