Baxter Spectrum IQ Infusion Pump Recalled for Defective AC Power Adapter
Baxter Healthcare is recalling 408 Spectrum IQ infusion pumps because a potentially defective AC power adapter may fail over time.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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: The recall involves a medical device with a component that may fail, posing a risk of harm to patients, but the source text does not report any specific injuries, illnesses, or deaths.
Plain-English summary
Baxter Healthcare Corporation is recalling 408 units of the Spectrum IQ Infusion Pump. The product is intended for the controlled administration of fluids. The recall is due to a potentially defective component in the AC power adapter which may fail over time.
The affected units were distributed worldwide and nationwide in the United States, specifically in the states of AL, AR, CA, CT, FL, IA, IN, LA, MA, MD, ME, MN, MO, MS, MT, NC, NJ, NY, OH, PA, RI, SC, TN, TX, and Puerto Rico. The specific serial numbers for the affected units are listed in the official recall documentation.
Consumers and healthcare facilities should stop using the affected infusion pumps and contact Baxter Healthcare Corporation for further instructions on the recall.
The recalled product
- Product
- Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids.
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 408
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 (20)
- Product Code: 3570009 Serial Numbers: 3008222
- 3539596
- 3546215
- 3586366
- 3619652
- 3622541
- 3623709
- 3624381
- 3624740
- 3625247
- 3011477
- 3539777
- 3547110
- 3586582
- 3619759
- 3622688
- 3623721
- 3624383
- 3624744
- 3625266
Distribution
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