Alaris Pump Module Model 8100 — Class I medical device recall Z-2205-2012
Terminated recall by CareFusion 303, Inc., reported 2012-08-29, distributed nationwide. The recall was initiated because Carefusion has identified a potential risk associated with the Alaris Pump mo
| Recall number | Z-2205-2012 |
|---|---|
| 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 | 2012-06-15 |
| Classified | 2012-08-17 |
| Reported by FDA | 2012-08-29 |
| Terminated | 2014-05-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, ZA |
| Model numbers | 8100 |
Product
Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates.
Reason for recall
The recall was initiated because Carefusion has identified a potential risk associated with the Alaris Pump module model 8100. The pump module door keypad overlay may separate from the keypad assembly
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-2205-2012. 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.