Baxter Spectrum Wireless Battery Modules May Fail to Document Infusion Status
Baxter Spectrum Wireless Battery Modules may fail to automatically transmit infusion status information to hospital electronic medical records systems. The software issue affects 17,377 units nationwide.
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: FDA Class II recall involving a risk-of-harm product. The failure to auto-document infusion status to hospital EMR systems could result in clinical documentation gaps affecting patient monitoring and care decisions on critical medical devices, without reported injuries to date.
Plain-English summary
Baxter Healthcare Corporation is recalling Spectrum Wireless Battery Modules (product code 35223) used with Spectrum V8 and Spectrum IQ infusion pumps. The recall affects 17,377 units distributed nationwide with radio software versions 22D28, 22D29, and 22D30.
The affected wireless battery modules may fail to automatically transmit infusion status information to a hospital's Electronic Medical Record (EMR) system. This software issue only occurs when the infusion pump is integrated with the hospital's EMR system.
The recall affects healthcare facilities nationwide that use these Spectrum infusion pumps integrated with their EMR systems. Patients receiving infusions through recalled units may have incomplete or delayed status updates reflected in their electronic medical records.
Healthcare facilities using affected equipment should contact Baxter Healthcare Corporation for guidance and software updates.
The recalled product
- 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
- 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 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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