Reported Dec 7, 2016 · Terminated
V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LLC Medina,…
Baxter Healthcare Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corp. · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LLC Medina
- NY 14103 --- NOTEThe 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
- Lot codes and dates
Product Code 35701distributed between 02/04/2015 - 06/02/2015
- Amount recalled
- 439 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
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.
This product could cause temporary or reversible health problems — stop using it.
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