Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported October 28, 2020
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
Baxter is updating the device IFU for safety communication regarding cleaning practices.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Baxter Healthcare Corporation recalled Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - a critical-severity action.
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) was recalled by Baxter Healthcare Corporation in October 28, 2020. Reason: Baxter is updating the device IFU for safety communication regarding cleaning practices.. Check the official notice for the remedy. Verify recall #Z-0120-2021 with the FDA Devices before acting.
The recall
Baxter Healthcare Corporation issued this critical-severity FDA Devices recall-Baxter is updating the device IFU for safety communication regarding cleaning practices..
- Critical
- severity level
- 9K units
- affected scope
- Class I
- classification
- October 28, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0120-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0120-2021) was formally reported on October 28, 2020, with the manufacturer initiating the action on June 30, 2020. It is classified under Critical severity (Class I), with a current status of Terminated. Baxter Healthcare Corporation is listed as the recalling firm, operating out of Deerfield, IL. Federal records list the affected scope as 9352 units.
The documented reason for this recall is: Baxter is updating the device IFU for safety communication regarding cleaning practices. Distribution data in the federal record shows the product reached: 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). Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Where this recall sits in the database
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
9352 units
Related Recalls
6
0 from same agency
Product description
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
Reason for recall
Baxter is updating the device IFU for safety communication regarding cleaning practices.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0120-2021 |
| Date reported | October 28, 2020 |
| Date initiated | June 30, 2020 |
| Recalling firm | Baxter Healthcare Corporation |
| Firm location | Deerfield, IL |
| Affected scope | 9352 units |
| Distribution | 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) |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0120-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6). Recalled by Baxter Healthcare Corporation. Units affected: 9352 units.
Why was this product recalled? ▼
Baxter is updating the device IFU for safety communication regarding cleaning practices.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 28, 2020. Severity: Critical. Recall number: Z-0120-2021.
Where was the recalled product distributed? ▼
Distribution: 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).
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0120-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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What to do next
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported October 28, 2020.
- Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.