Alaris Pump Module model 8100 — Class I medical device recall Z-2185-2012

Terminated recall by CareFusion 303, Inc., reported 2012-08-22, distributed nationwide. The recall was initiated because Carefusion identified a potential risk associated with the Alaris Pump module

Recall number	`Z-2185-2012`
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	2012-06-29
Classified	2012-08-15
Reported by FDA	2012-08-22
Terminated	2015-08-26
Distributed	Nationwide (US)
Countries outside the US	CA, NL, ZA
Quantity	102,248 units
Model numbers	`8100`

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 for recall

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.

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-2185-2012. 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.