FDA Device recall Z-2185-2012
Alaris Pump Module model 8100
- FDA Device
- Class I
- terminated
- Published 2012-08-22
On 2012-08-22 the FDA classified a Class I recall of Alaris Pump Module model 8100 by Carefusion 303, citing the recall was initiated because Carefusion identified a potential risk associated with the Alaris Pump module model 8100. Carefusion has received reports of customers experiencin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2185-2012 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-06-29 |
| Published | 2012-08-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Carefusion 303 |
| Distribution | US |
Product
Alaris Pump Module model 8100. 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
The recall was initiated because Carefusion identified a potential risk associated with the Alaris Pump module model 8100. Carefusion has received reports of customers experiencing motor stalls during infusion with Alaris Pump Module (model 8100) manufactured between August 2010 and July 2011.
Identifiers
| code_info | All serial numbers associated with the Alaris Pump Module Model 8100: 8100 DEMO PUMP MODULE; 8100 Global Pump Module; 8…All serial numbers associated with the Alaris Pump Module Model 8100: 8100 DEMO PUMP MODULE; 8100 Global Pump Module; 8100 IOC Pump Module V8.5.29.0; 8100 LVP Training Unit; 8100 Pump Module V8.5.29.0; 8100 Pump Module V8.5.29.0 (V9); Medley Patient Care System LVP; Model 8100 Trade-In Material; RCND 8100 Pump Module V8.5.29.0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2185-2012%22
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