Spectrum IQ Infusion System Recalled for Connectivity Errors
Baxter Healthcare Corporation is recalling the Spectrum IQ Infusion System due to system errors causing pump connectivity failures following certain network configuration changes.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall classification. While no illnesses or deaths have been reported, connectivity errors in an infusion pump system could potentially affect patient safety and critical drug delivery functions.
Plain-English summary
The Spectrum IQ Infusion System with Dose IQ Safety Software (Product Code 3570009) is being recalled by Baxter Healthcare Corporation. System errors and Gateway Server System performance anomalies have resulted in excessive connectivity errors between the pump and network system, potentially affecting proper pump function.
The issue occurs when customers implement changes to their network and server system configurations. Approximately 130,135 units have been distributed across the United States (including Puerto Rico), Canada, Bahamas, Bermuda, Guyana, and Trinidad and Tobago. All serial numbers are affected by this recall.
Healthcare providers and patients should be aware of this Class I recall affecting the Spectrum IQ Infusion System. Users should contact Baxter Healthcare Corporation or their healthcare provider for guidance regarding affected units.
The recalled product
- Product
- Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Affected units
- 130,135
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 (1)
- All Serial Numbers
Distribution
Distributed in 1 state:
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