Baxter Healthcare Corp. recalls V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LLC Medina,…

Recall date

September 28, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0672-2017

FDA classification

Class II

Brand / firm

Baxter Healthcare Corp.

Sold / distributed

Nationwide Distribution, Puerto Rico and Canada

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- 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 Code 35701 is a replacement assembly that is shipped to customers for self-repair of the Spectrum Infusion Pump. It is not a registered finished good.