Home / Recalls / Baxter Healthcare Corp. / Z-0672-2017

Z-0672-2017 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

Recall Details

Product Type
Devices
Report Date
December 7, 2016
Initiation Date
September 28, 2016
Termination Date
June 15, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
439 units

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Nationwide Distribution, Puerto Rico and Canada

Code Information

Product Code 35701; distributed between 02/04/2015 - 06/02/2015.

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