Alaris Syringe Pump — Class I medical device recall Z-2362-2015
Terminated recall by CareFusion 303, Inc., reported 2015-08-26, distributed nationwide. Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syringe module. Afte
| Recall number | Z-2362-2015 |
|---|---|
| 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 | 2015-07-21 |
| Classified | 2015-08-14 |
| Reported by FDA | 2015-08-26 |
| Terminated | 2018-12-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, MY, NZ, TW, ZA |
| Quantity | 68,460 units |
| Reason classes | device malfunction |
| Model numbers | 148188-100, 49000226, 8110 |
Product
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
Reason for recall
Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syringe module. After the error is cleared on the PCU, the syringe pump is unresponsive to key presses until the next power cycle, or the module is detached and reattached.
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-2362-2015. 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.