FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
- Recall number
- Z-2530-2024
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
- Status
- Open, Classified
- Initiated
- 2024-06-14
- Posted
- 2024-08-07
- Terminated
- not on file
- Reason
- Improperly performed testing prior to release
- Root cause
- Under Investigation by firm
- Action
- The impacted customer was contacted via phone call on 6/14/2024. Baxter has asked the customer to locate the affected pump at their facility and return the device to Baxter to be serviced.
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution in the state of Florida.
- Lot, serial or model codes
- Product Code: 35700BAX2. Serial Number: 2158913.
- 510(k) numbers
- ["K230022"]
- 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