Recall events
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Event 86758
Event summary
Timeline bucket November 23, 2020
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording Baxter Healthcare Corporation
Dossier provenance
Source snapshots represented here
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.
How coverage and grouping work
Complete imported group
Every recalled product in this event
4 official enforcement rows
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) - Product Usage: intended to be used for the controlled administration of fluids.
Z-0712-2021
Recall number Z-0712-2021
Initiated November 23, 2020
Classification Class II
Status Ongoing
Quantity 9,353 devices
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
software error
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0712-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4597]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
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Reason for recall There is a potential software error during programming.
Code information Product Code 35700ABB, GTIN 00085412091570
Distribution pattern Worldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[32416]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 4
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
Z-0713-2021
Recall number Z-0713-2021
Initiated November 23, 2020
Classification Class II
Status Ongoing
Quantity 293,926 devices
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
software error
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0713-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[22262]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential software error during programming.
Code information Product Code 35700BAX, GTIN 00085412091587
Distribution pattern Worldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[34713]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 4
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids.
Z-0714-2021
Recall number Z-0714-2021
Initiated November 23, 2020
Classification Class II
Status Ongoing
Quantity 140,006 devices
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
software error
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0714-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4596]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential software error during programming.
Code information Product Code 35700BAX2, GTIN 00085412498683
Distribution pattern Worldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[33943]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 4
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of fluids.
Z-0715-2021
Recall number Z-0715-2021
Initiated November 23, 2020
Classification Class II
Status Ongoing
Quantity 112,463 devices
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
software error
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0715-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16322]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential software error during programming.
Code information Product Code 3570009, GTIN 00085412610900
Distribution pattern Worldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[35750]
FDA event record
· Exact recall-number query on openFDA
