The Recall Desk
ModerateFDA (Devices)·Z-0671-2017·Announced 2016-12-07

Baxter SIGMA Spectrum Infusion Pump Recall for Speaker Failure

Baxter is recalling SIGMA Spectrum Infusion Pumps to replace speakers that may fail prematurely, potentially affecting audible alarm tones.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states that pumps with non-functional speakers will continue to display visual alarm indications and operate as intended, indicating a low-risk, precautionary recall without reported injuries.

Plain-English summary

Baxter Healthcare Corporation is recalling SIGMA Spectrum Infusion Pumps with Master Drug Library to replace speakers that have an increased potential to fail prematurely. The speakers are part of the rear case assembly and are intended to generate audible tones during keystrokes and alarm conditions. Some speakers have a variation in internal wiring that contributes to this risk.

The recall affects 15,517 units distributed nationwide in the United States, Puerto Rico, and Canada. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications and will otherwise continue to operate as intended. The recall is a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.

Healthcare facilities and users should contact Baxter Healthcare Corporation for instructions on replacing the affected speakers. A list of affected serial numbers is available through the FDA's Center for Devices and Radiological Health (CDRH).

The recalled product

Product
Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product Code 35700BAX2, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Baxter Healthcare Corporation, Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly
Manufacturer
Baxter Healthcare Corp.
Category
Medical Device — Infusion Pump
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Contact CDRH for list of affected serial numbers (15
  • 517).

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Baxter Healthcare Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Baxter Healthcare Corp.

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Same hazard · component failure

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