Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 22, 2015
Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled administration of fluids.
Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump during programming may differ. MDL drug dose time in seconds will round to the nea…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Baxter Healthcare Corp recalled Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA S… - a moderate-severity action.
Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA S… was recalled by Baxter Healthcare Corp in April 22, 2015. Reason: Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump during progra…. Check the official notice for the remedy. Verify recall #Z-1451-2015 with the FDA Devices before acting.
The recall
Baxter Healthcare Corp issued this moderate-severity FDA Devices recall-Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump during progra….
- Moderate
- severity level
- Class II
- classification
- April 22, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1451-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1451-2015) was formally reported on April 22, 2015, with the manufacturer initiating the action on March 2, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Baxter Healthcare Corp is listed as the recalling firm, operating out of Deerfield, IL. Federal records list the affected scope as 58 MDLs.
The documented reason for this recall is: Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump during programming may differ. MDL drug dose time in seconds will round to the nearest integer in minutes on the pump dose… Distribution data in the federal record shows the product reached: Worldwide Distribution: US Distribution to states of: CA, CT, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NE, NH, NY, SD, TX, UT, WV, including Puerto Rico and country of: Canada.. 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, 3 from FDA Devices - 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
58 MDLs
Related Recalls
6
3 from same agency
Product description
Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled administration of fluids.
Reason for recall
Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump during programming may differ. MDL drug dose time in seconds will round to the nearest integer in minutes on the pump dose setup screen (20 sec may show as 1 min on the pump display). The pump will administer drugs as configured. The discrepancy may cause therapy delay or unintended rate of delivery.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1451-2015 |
| Date reported | April 22, 2015 |
| Date initiated | March 2, 2015 |
| Recalling firm | Baxter Healthcare Corp |
| Firm location | Deerfield, IL |
| Affected scope | 58 MDLs |
| Distribution | Worldwide Distribution: US Distribution to states of: CA, CT, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NE, NH, NY, SD, TX, UT, WV, including Puerto Rico and country of: Canada. |
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-1451-2015) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼
Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled administration of fluids.. Recalled by Baxter Healthcare Corp. Units affected: 58 MDLs.
Why was this product recalled? ▼
Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump during programming may differ. MDL drug dose time in seconds will round to the nearest integer in minutes on the pump dose setup screen (20 sec may show as 1 min on the pump display). The pump will administer drugs as configured. The discrepancy may cause therapy delay or unintended rate of delivery.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 22, 2015. Severity: Moderate. Recall number: Z-1451-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US Distribution to states of: CA, CT, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NE, NH, NY, SD, TX, UT, WV, including Puerto Rico and country of: Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1451-2015) 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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 22, 2015. 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.