FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
- Recall number
- Z-0348-2025
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
- Status
- Open, Classified
- Initiated
- 2024-10-02
- Posted
- 2024-11-08
- Terminated
- not on file
- Reason
- The door on the Spectrum IQ Infusion pump may not be able to fully close.
- Root cause
- Process control
- Action
- Baxter Healthcare notified its consignees on 10/03 and 04/2024 via telephone. The call included information regarding the problem with the device, risk to health, and requested the affected units be removed from service pending inspection. On-site inspections to assess for impact and offer replacement, were scheduled.
- Quantity
- 8 units
- Distribution
- GA, ID
- Lot, serial or model codes
- 00085412610900, Serial Numbers: 3796578, 3797382, 3797464, 3797578, 3797728, 3797733, 3798019, 3798200
- 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