FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.
- Recall number
- Z-1484-2014
- Recalling firm
- Baxter Healthcare Corp.
- Product
- SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.
- Status
- Terminated
- Initiated
- 2014-02-07
- Posted
- 2014-04-25
- Terminated
- 2017-05-25
- Reason
- Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library due to repeated System Error 322 occurrences.
- Root cause
- Software design
- Action
- On February 7, 2014, Baxter Healthcare Corporation distributed Urgent Device Correction notices and Customer Reply Forms to their customers via first-class mail. Affected customers are instructed to contact Baxter Healthcare Corporation at 1-800-356-3454 (choose option 1) Monday through Friday during the hours of 7:00 am to 7:00 pm Eastern Time. Baxter technicians would determine if an adjustment or repair is necessary. Customers are asked to complete the attached Customer Reply Form and return it to Baxter either by faxing to 1-224-270-5457 or e-mailing a scanned copy to fca@baxter.com.
- Quantity
- 277,096 units (revised)
- Distribution
- Worldwide Distribution - USA Nationwide including PR and the country of Canada.
- Lot, serial or model codes
- Product Codes: 35700BAX, 35700ABB
- 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