Baxter Healthcare Corp.: Medical Device Recall in 2013 - (Recall #: Z-0197-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.

Product Classification:

Class II

Date Initiated: June 10, 2013

Date Posted: November 20, 2013

Recall Number: Z-0197-2014

Event ID: 66120

Reason for Recall:

Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms occurring during infusions.

Status: Terminated

Product Quantity: 273,835 units

Code Information:

Product Code: 35700BAX, 35700ABB Serial Numbers: All

Distribution Pattern:

Worldwide Distribution-USA including Puerto Rico and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated