FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Spectrum IQ Infusion Pump, Product Code 3570009
- Recall number
- Z-2415-2025
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Spectrum IQ Infusion Pump, Product Code 3570009
- Status
- Open, Classified
- Initiated
- 2025-07-14
- Posted
- 2025-08-22
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- Customers were contacted via telephone beginning 7/14/25. The included information about the product, the issue and the action to be taken by the customers. Baxter Healthcare is requesting the return of the impacted product to perform all tests required and confirm that the product perform as expected. If you have any questions, phone (Toll Free): 800-422-9837 or 847-948-4770; hours of operation: Monday through Friday from 8:00 am to 5:00 pm CST
- Quantity
- 6 units
- Distribution
- US distribution to states of: AZ, FL
- Lot, serial or model codes
- UDI-DI: 00085412610900; Serial Numbers: 3815255 3815261 3815265 3815266 3815267 3815271
- 510(k) numbers
- ["K230041"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28