FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Baxter Spectrum IQ Infusion Pump, Product Code 3570009
- Recall number
- Z-1775-2024
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Baxter Spectrum IQ Infusion Pump, Product Code 3570009
- Status
- Open, Classified
- Initiated
- 2024-03-20
- Posted
- 2024-05-03
- Terminated
- not on file
- Reason
- One device was improperly performed testing prior to release from a Service Center.
- Root cause
- Nonconforming Material/Component
- Action
- The affected customer was contacted via on-site visit on March 20, 2024, and by phone call on March 22, 2024. Baxter has asked the customer to locate the affected pump at their facility and return the device to Baxter for testing.
- Quantity
- 1 pump
- Distribution
- US Nationwide distribution in the state of Massachusetts.
- Lot, serial or model codes
- UDI/DI 00085412610900, Serial Number 3540772
- 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