Master Drug Library Software version 8 — Class II medical device recall Z-1451-2015
Terminated recall by Baxter Healthcare Corp, reported 2015-04-22, distributed in CA, CT, FL, IA, IL, IN, LA, MA…. Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump during program
| Recall number | Z-1451-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp, Deerfield, IL, United States |
| Recall initiated | 2015-03-02 |
| Classified | 2015-04-16 |
| Reported by FDA | 2015-04-22 |
| Terminated | 2018-05-22 |
| Distributed | CA, CT, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NE, NH, NY, PR, SD, TX, UT, WV |
| Countries outside the US | CA |
| Quantity | 58 mdls |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1451-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.