Baxter Spectrum IQ Infusion Pump recalled due to improper pre-release testing
Baxter Healthcare is recalling one Spectrum IQ Infusion Pump that underwent improper testing before release. The device was distributed nationwide including in Massachusetts.
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: This is an FDA Class II medical device recall due to quality control failure—specifically, improper testing prior to device release. No illnesses, injuries, or actual device malfunctions have been reported. This qualifies as a risk-of-harm product where no injury has been reported, meeting the rubric criterion for High severity.
Plain-English summary
Baxter Healthcare Corporation is recalling one Spectrum IQ Infusion Pump (Product Code 3570009, Serial Number 3540772) due to improper pre-release testing. The device underwent inadequate testing procedures at a Baxter Service Center prior to distribution.
The affected infusion pump was distributed nationwide, including in Massachusetts. Because the device did not receive proper testing verification before release, its safety and performance characteristics could not be fully confirmed.
Healthcare facilities and patients with this device should contact Baxter Healthcare Corporation or the U.S. Food and Drug Administration for guidance on appropriate action regarding the affected unit.
The recalled product
- Product
- Baxter Spectrum IQ Infusion Pump, Product Code 3570009
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Affected units
- 1
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 Number 3540772
Distribution
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