Spectrum Wireless Battery Modules fail to auto-document infusion status
Spectrum Wireless Battery Modules may fail to send infusion status updates to hospital electronic medical records. The issue affects 17,377 units nationwide used with Spectrum V8 and IQ infusion pumps.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II recall presents risk-of-harm through missing EMR documentation during infusion therapy, which could impact care coordination. No illnesses or injuries have been reported, placing this at the High level per the rubric for risk-of-harm products without reported injury.
Plain-English summary
Baxter Healthcare Corporation is recalling 17,377 Spectrum Wireless Battery Modules (product code 36010) that may fail to automatically send infusion status information to hospital electronic medical record (EMR) systems. The affected units have radio software versions 22D28, 22D29, or 22D30 and are used with either the Spectrum V8 or Spectrum IQ infusion pump.
This software issue only impacts hospitals where the infusion pump system is integrated with an EMR system. When modules fail to auto-document infusion status information, this could affect hospital care coordination and medication management.
Healthcare facilities should contact Baxter Healthcare Corporation to identify affected units and obtain further instructions.
The recalled product
- 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)
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 17,377
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Pump UDI/DI GTIN 00085412498683
- All serial numbers with radio software versions 22D28
- 22D29
- and 22D30
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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