CareFusion 303, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2205-2012)

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 (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.

Product Classification:

Class I

Date Initiated: June 15, 2012

Date Posted: August 29, 2012

Recall Number: Z-2205-2012

Event ID: 62642

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

Status: Terminated

Product Quantity: 43,862 units total (40,780 units in the US)

Code Information:

Model 8100; Lot/Serial numbers-various

Distribution Pattern:

Worldwide Distribution-USA (nationwide) and the countries of Australia, European Union, and South Africa.

Voluntary or Mandated:

Voluntary: Firm initiated