Z-2581-2024 Class II Ongoing
FDA device recall Z-2581-2024 was initiated by Baxter Healthcare Corporation on Jul 17, 2024 and is designated Class II. Reason for recall: The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8… The recall status is ongoing. Affected quantity: 17,377 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 28, 2024
- Initiation Date
- Jul 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,377 units
Product Description
Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spectrum V8 Infusion Pump
Reason for Recall
The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the hospital s EMR system.
Distribution Pattern
US, Nationwide
Code Information
Pump GTIN 00085412498683; All serial numbers with radio software versions 22D28, 22D29, and 22D30
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2581-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026