openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 4
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
Baxter is updating the device IFU for safety communication regarding cleaning practices.
Code information
Product Code: 35700ABB, All Serial Numbers; GTIN 00085412091570
Distribution pattern
Distribution throughout the United States, St. Thomas USVI, and Puerto Rico. Foreign distribution including Canada, Caribbean (Barbados, Trinidad and Tobago, Jamaica, Bahamas, Bermuda, and Guyana)
device · product 2 of 4
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
Baxter is updating the device IFU for safety communication regarding cleaning practices.
Code information
Product Code: 35700BAX, All Serial Numbers; GTIN 00085412091570
Distribution pattern
Distribution throughout the United States, St. Thomas USVI, and Puerto Rico. Foreign distribution including Canada, Caribbean (Barbados, Trinidad and Tobago, Jamaica, Bahamas, Bermuda, and Guyana)
device · product 3 of 4
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
Baxter is updating the device IFU for safety communication regarding cleaning practices.
Code information
Product Code: 35700BAX2, All Serial Numbers; GTIN 00085412498683
Distribution pattern
Distribution throughout the United States, St. Thomas USVI, and Puerto Rico. Foreign distribution including Canada, Caribbean (Barbados, Trinidad and Tobago, Jamaica, Bahamas, Bermuda, and Guyana)
device · product 4 of 4
Spectrum IQ Infusion System with Dose IQ Safety Software
Baxter is updating the device IFU for safety communication regarding cleaning practices.
Code information
Product Code: 3570009, All Serial Numbers; GTIN 00085412610900
Distribution pattern
Distribution throughout the United States, St. Thomas USVI, and Puerto Rico. Foreign distribution including Canada, Caribbean (Barbados, Trinidad and Tobago, Jamaica, Bahamas, Bermuda, and Guyana)
