Spectrum IQ Infusion Pumps Recalled for Potential Lubricant Failure
Baxter is recalling six Spectrum IQ Infusion Pumps distributed to Arizona and Florida due to potential grease breakdown in the motor mechanism, which could result in excessive medication delivery.
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: This is a risk-of-harm product recall involving potential patient medication overdose from device lubrication failure. FDA Class II classification with theoretical hazard supports a High (3) severity rating.
Plain-English summary
Baxter Healthcare Corporation is recalling six Spectrum IQ Infusion Pumps (Product Code 3570009) distributed to Arizona and Florida. The device's motor mechanism uses grease on the cam and motor gears that may break down prematurely.
Baxter has identified that certain pumps were released with grease that breaks down quickly. The breakdown results in insufficient or ineffective lubrication on the cam, leading to potential premature wear of the mechanism assembly. This wear could result in excessive medication delivery to patients.
The affected pumps are identified by serial numbers: 3815255, 3815261, 3815265, 3815266, 3815267, and 3815271.
The recalled product
- Product
- Spectrum IQ Infusion Pump, Product Code 3570009
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Hazard
- lubricant-failure
- medication-overdose
- device-malfunction
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)
- UDI-DI: 00085412610900
- Serial Numbers: 3815255 3815261 3815265 3815266 3815267 3815271
Distribution
Distributed in 2 states:
- AZ
- FL
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