Z-1451-2015 Class II Terminated
FDA device recall Z-1451-2015 was initiated by Baxter Healthcare Corp on Mar 2, 2015 and is designated Class II. 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… The recall status is terminated (terminated May 22, 2018). Affected quantity: 58 MDLs.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 22, 2015
- Initiation Date
- Mar 2, 2015
- Termination Date
- May 22, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 58 MDLs
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.
Distribution Pattern
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.
Code Information
Software version 8.0, Product Code 35723V080
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1451-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026