FDA Enforcement
Class II
Ongoing
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)
Recall: Z-2582-2024
·
Reported August 28, 2024
Enforcement
- Recall Number
- Z-2582-2024
- Event ID
- 94988
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Baxter Healthcare Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 28, 2024
- Initiation Date
- July 17, 2024
- Classification Date
- August 16, 2024
- Address
- 1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States
Description
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.
Code Info
Pump UDI/DI GTIN 00085412498683; All serial numbers with radio software versions 22D28, 22D29, and 22D30
Distribution
US, Nationwide
Quantity
17,377 units