Company: Baxter Healthcare Corporation
Date of Enforcement Report: 8/16/2024
Class II
PRODUCT
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.
Recall Number:
Z-2581-2024
REASON:
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.
RECALLING FIRM/MANUFACTURER:
Baxter Healthcare Corporation
VOLUME OF PRODUCT IN COMMERCE:
17,377 units
DISTRIBUTION:
US, Nationwide
