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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Baxter Healthcare Corporation: Spectrum Wireless Battery Modules Recalled for EMR Data Sync Failure

Agency Publication Date: August 16, 2024
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Summary

Baxter Healthcare Corporation has recalled approximately 34,754 Spectrum Wireless Battery Modules used with Spectrum V8 and Spectrum IQ infusion pumps. A software issue can prevent these modules from automatically sending critical infusion status information to a hospital's Electronic Medical Record (EMR) system. This failure occurs in facilities where the infusion system is integrated with the EMR, potentially leading to incomplete patient records. Consumers should contact the manufacturer or their healthcare provider for further instructions.

Risk

The software defect causes a failure in auto-documentation, meaning medical staff may not see real-time infusion data in the patient's electronic chart, which could lead to medical errors or delayed clinical decisions.

What You Should Do

  1. Identify if your facility uses Baxter Spectrum Wireless Battery Modules (A/B/G/N) with product codes 35223 or 36010.
  2. Check the pump GTIN for number 00085412498683 and verify the radio software version on your devices.
  3. Identify affected units by looking for radio software versions 22D28, 22D29, and 22D30.
  4. If your system is integrated with a hospital Electronic Medical Record (EMR) system, be aware that infusion status may fail to auto-document and manual verification may be required.
  5. Contact Baxter Healthcare Corporation at 1-888-463-6332 or your internal healthcare technology department for technical guidance and instructions on software updates.
  6. For any additional questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and software support

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Baxter Spectrum Wireless Battery Modules A/B/G/N (used with Spectrum V8 or Spectrum IQ infusion pumps)
Model / REF:
35223
35700BAX2 (Spectrum V8 infusion pump)
3570009 (Spectrum IQ infusion pump)
UPC Codes:
00085412498683
Lot Numbers:
Radio software version 22D28
Radio software version 22D29
Radio software version 22D30
Product: Spectrum Wireless Battery Modules A/B/G/N (used with Spectrum V8 and Spectrum IQ infusion pumps)
Model / REF:
36010
35700BAX2 (Spectrum V8 infusion pump)
3570009 (Spectrum IQ infusion pump)
UPC Codes:
00085412498683
Lot Numbers:
Radio software version 22D28
Radio software version 22D29
Radio software version 22D30

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94988
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Baxter Healthcare Corporation
Manufactured In: United States
Units Affected: 2 products (17,377 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท FDA Press Release ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.