FDA Medical devices recall ·
Spectrum IQ Infusion Pump, Product Code 3570009 recall
- Recall number
- Z-2415-2025
- Date
- (initiated July 14, 2025)
- Company / brand
- Baxter Healthcare Corporation
1 Baxter Pkwy, Deerfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 6 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Spectrum IQ Infusion Pump, Product Code 3570009
Why was it recalled?
Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00085412610900; Serial Numbers: 3815255 3815261 3815265 3815266 3815267 3815271
Distribution
US distribution to states of: AZ, FL
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2415-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.