The Recall Desk
ModerateFDA (Devices)·Z-0670-2017·Announced 2016-12-07

Baxter Recalls Sigma Spectrum Infusion Pumps Due to Speaker Failure Risk

Baxter Healthcare is recalling 5,976 Sigma Spectrum Infusion Pumps because some speakers may fail prematurely, potentially affecting audible alarms.

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. The hazard involves a component failure (speaker) that may reduce audible alarms, but the device continues to provide visual alarms and operate as intended, representing a moderate risk without reported injuries.

Plain-English summary

Baxter Healthcare Corp. is recalling 5,976 units of the Sigma Spectrum Volumetric Infusion Pump with Master Drug Library (Product Codes 35700BAX and 35700BAXR). The recall involves pumps distributed nationwide in the United States, Puerto Rico, and Canada.

The recall is issued to replace speakers installed in the pumps or included in spare part rear case assemblies. Some speakers have a variation in internal wiring that increases the potential for the speaker to fail prematurely. The speakers are intended to generate audible tones during keystrokes and alarm conditions. Pumps with non-functional speakers will continue to display visual alarm indications and otherwise operate as intended.

Healthcare facilities and users should contact Baxter Healthcare or CDRH for a list of affected serial numbers and instructions on replacing the speakers.

The recalled product

Product
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 loca
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 (1)

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

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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