Baxter Spectrum IQ Infusion System Recall for Safety Communication Update
Baxter Healthcare is recalling 146,224 Spectrum IQ Infusion Systems to update instructions for use regarding cleaning practices.
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: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Baxter is updating the device IFU for safety communication regarding cleaning practices."
Plain-English summary
Baxter Healthcare Corporation is recalling 146,224 units of the Spectrum IQ Infusion System with Dose IQ Safety Software. The recall is initiated to update the device Instructions for Use (IFU) to improve safety communication regarding cleaning practices.
The affected products are identified by Product Code 3570009 and include all serial numbers. The GTIN for the product is 00085412610900.
Distribution of the recalled units occurred throughout the United States, St. Thomas USVI, and Puerto Rico. Foreign distribution included Canada and several Caribbean nations, specifically Barbados, Trinidad and Tobago, Jamaica, Bahamas, Bermuda, and Guyana. Consumers and healthcare facilities should refer to the updated instructions for use provided by the manufacturer for proper cleaning procedures.
The recalled product
- Product
- Spectrum IQ Infusion System with Dose IQ Safety Software
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 146,224
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 (3)
- Product Code: 3570009
- All Serial Numbers
- GTIN 00085412610900
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 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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