Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0672-2017·Announced 2016-12-07

Baxter Recalls SIGMA Spectrum Infusion Pump Rear Case Assemblies

Baxter Healthcare is recalling 439 V6 Rear Case Assemblies for SIGMA Spectrum Infusion Pumps because the speakers may fail prematurely.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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: This is a Class II recall involving a component failure that reduces alarm functionality but does not cause direct harm, fitting the criteria for moderate severity.

Plain-English summary

Baxter Healthcare Corp. is recalling 439 units of the V6 Rear Case Assembly, Product Code 35701, which serves as a replacement part for the SIGMA Spectrum Infusion Pump. These assemblies were distributed nationwide, to Puerto Rico, and to Canada between February 4, 2015, and June 2, 2015.

The recall is being issued because some speakers included in the rear case assemblies have a variation in their 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. If the speaker fails, the infusion pump will continue to display visual alarm indications and will otherwise continue to operate as intended.

The recalled product is a replacement assembly shipped to customers for self-repair of the Spectrum Infusion Pump. It is not a registered finished good. Customers should contact Baxter Healthcare Corp. for instructions on how to replace the affected assemblies.

The recalled product

Product: 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…
Manufacturer: Baxter Healthcare Corp.
Category: Medical Device — Infusion Pump Component
Hazard: component-failure
alarm-malfunction
Affected units: 439

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)

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

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 →

Same manufacturer · Baxter Healthcare Corp.

See all →

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Same hazard · component failure