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.
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: 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…
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Medical Device — Infusion Pump
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
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.
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