FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
- Recall number
- Z-0713-2021
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
- Status
- Open, Classified
- Initiated
- 2020-11-23
- Posted
- not on file
- Terminated
- not on file
- Reason
- There is a potential software error during programming.
- Root cause
- Under Investigation by firm
- Action
- A Medical Device Correction communication will be sent to all affected customers via U.S.P.S., first class mail. All pumps will be updated with new software which will prevent the malfunction from occurring. The software upgrade will be implemented upon next service or a local Baxter service representative will contact the facility to determine the correction plan and schedule the software update.
- Quantity
- 293,926 devices
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.
- Lot, serial or model codes
- Product Code 35700BAX, GTIN 00085412091587
- 510(k) numbers
- ["K042121"]
- 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