Baxter Healthcare Corp.: Medical Device Recall in 2016 - (Recall #: Z-0670-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 35700BAXR, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Sigma, LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended.

Product Classification:

Class II

Date Initiated: September 28, 2016

Date Posted: December 7, 2016

Recall Number: Z-0670-2017

Event ID: 75311

Reason for Recall:

A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increased potential to fail prematurely.

Status: Terminated

Product Quantity: 5,976 units (US: 5972, Canada: 4)

Code Information:

Contact CDRH for list of affected serial numbers (5976 units)

Distribution Pattern:

Nationwide Distribution, Puerto Rico and Canada

Voluntary or Mandated:

Voluntary: Firm initiated