Baxter Spectrum IQ Infusion Pumps Recalled Due to Potential Medication Delivery Failure
Baxter Healthcare is recalling 241,304 Spectrum IQ infusion pumps due to potential medication delivery failure without user alert. The issue may occur during administration set setup or when occlusion alarms are not fully resolved.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity score of 4 per the rubric. Although no illnesses or injuries have been reported, the potential for medication non-delivery in infusion pumps represents a serious risk to patients dependent on continuous medication delivery.
Plain-English summary
Baxter Healthcare Corporation is recalling Spectrum IQ infusion pumps (Product code 3570009) due to a potential hazard affecting medication delivery.
The pumps may deliver reduced or no medication in some cases without alerting the user via pump alarm. This can occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps.
The recall affects 241,304 units with GTIN 00085412610900 and all serial numbers. Distribution was worldwide, including the US, Puerto Rico, St. Thomas, government/military distribution, and internationally to Canada, Bahamas, Barbados, Bermuda, Guyana, Jamaica, and Trinidad and Tobago.
Healthcare providers and patients using these pumps should contact Baxter Healthcare Corporation for further information and guidance regarding this recall.
The recalled product
- Product
- Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Hazard
- medication-delivery-failure
- alarm-failure
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)
- All serial numbers
- GTIN 00085412610900.
Distribution
Distributed nationwide across the United States.
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