RecallRadar

FDA Device recall Z-2582-2024

Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and…

On 2024-08-28 the FDA classified a Class II recall of Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and… by Baxter Healthcare, citing 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 wh….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2582-2024
ClassificationClass II
Statusongoing
Initiated2024-07-17
Published2024-08-28
Last updated2026-09-13 11:57 UTC
CompanyBaxter Healthcare
DistributionUS

Product

Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and 3570009 (Spectrum IQ infusion pump)

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.

Identifiers

code_infoPump UDI/DI GTIN 00085412498683; All serial numbers with radio software versions 22D28, 22D29, and 22D30

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2582-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.