Baxter Recalls SIGMA SPECTRUM Infusion Pumps Due to Alarm Issues
Baxter Healthcare is recalling SIGMA SPECTRUM Infusion Pumps because they may trigger false upstream occlusion or air-in-line alarms during use.
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 3/5 (High).
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 is classified as FDA Class II, and the hazard involves a medical device malfunction (false alarms) that poses a risk of harm to patients, fitting the 'High' severity 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 Infusion Pump with Master Drug Library. The recall involves 273,835 units of the device, which is intended for the controlled administration of intravenous fluids. The affected products are identified by Product Codes 35700BAX and 35700ABB and include all serial numbers.
The recall was initiated due to reports of upstream occlusion alarms and air-in-line alarms occurring during infusions. These alarms may indicate potential issues with the pump's ability to accurately monitor the infusion process. The affected units were distributed worldwide, including the United States, Puerto Rico, and Canada.
Healthcare facilities and consumers should stop using the affected SIGMA SPECTRUM Infusion Pumps and contact Baxter Healthcare for further instructions on how to proceed with the correction.
The recalled product
- Product
- SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Medical Device — Infusion Pump
- Affected units
- 273,835
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: 35700BAX
- 35700ABB Serial Numbers: All
Distribution
Distributed in 1 state:
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