Baxter Spectrum IQ Infusion Pump Door May Not Close Fully
Baxter is recalling 8 units of its Spectrum IQ Infusion System with Dose IQ Safety Software because the pump door may not fully close. The recall affects units distributed in Georgia and Idaho.
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 an FDA Class II medical device recall with no reported illnesses or injuries. The hazard—a door that may not fully close on a medical infusion pump—represents a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity rating.
Plain-English summary
Baxter Healthcare Corporation is recalling 8 units of the Spectrum IQ Infusion System with Dose IQ Safety Software (Product Code 3570009) because the door on the pump may not be able to fully close.
The affected units were distributed in Georgia and Idaho.
The recalled units have serial numbers 3796578, 3797382, 3797464, 3797578, 3797728, 3797733, 3798019, and 3798200. Code 00085412610900 is associated with these units.
The recalled product
- Product
- Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Hazard
- door-defect
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 (9)
- 00085412610900
- Serial Numbers: 3796578
- 3797382
- 3797464
- 3797578
- 3797728
- 3797733
- 3798019
- 3798200
Distribution
Distributed in 2 states:
- GA
- ID
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