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.
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 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
- Affected units
- 241,304
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
Part of a larger recall action
This product is one of 2 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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