Baxter Recalls Sigma Spectrum Volumetric Infusion Pumps Due to System Errors
Baxter Healthcare is recalling Sigma Spectrum Volumetric Infusion Pumps due to repeated System Error 322 occurrences.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used for intravenous administration where a system error could impact patient safety, but the source text does not report any injuries, illnesses, or deaths, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library. The recall is due to repeated System Error 322 occurrences.
The affected products are intended for the controlled administration of intravenous fluids, including pharmaceutical drugs, blood, blood products, and mixtures of required patient therapy. The recall covers 277,096 units.
Distribution was worldwide, including the USA nationwide (including Puerto Rico) and Canada. Product codes are 35700BAX and 35700ABB. The source text does not specify specific actions for consumers or healthcare providers beyond the issuance of the correction.
The recalled product
- Product
- SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, bl
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 277,096
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 Codes: 35700BAX
- 35700ABB
Distribution
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