Alaris Pump Module — Class I medical device recall Z-0950-2017
Terminated recall by CareFusion 303, Inc., reported 2017-01-25, distributed nationwide. During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted.
| Recall number | Z-0950-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2016-12-02 |
| Classified | 2017-01-18 |
| Reported by FDA | 2017-01-25 |
| Terminated | 2018-07-24 |
| Distributed | Nationwide (US) |
| Quantity | 382,635 units |
| Model numbers | 8100 |
Product
Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. 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 IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural
Reason for recall
During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted.
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-0950-2017. 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.