CareFusion 303, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2185-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class I

Date Initiated: June 29, 2012

Date Posted: August 22, 2012

Recall Number: Z-2185-2012

Event ID: 55121

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.

Status: Terminated

Product Quantity: 102,248 units

Code Information:

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

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and the countries of: South Africa and Canada. Additional Countries: Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated