Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy

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.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices

Baxter SIGMA Spectrum Infusion Pumps Recalled for Testing Failure After Repair

Agency Publication Date: December 27, 2024
Share:
Sign in to monitor this recall

Summary

Baxter Healthcare Corporation is recalling two SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 6 and Version 8). These devices were released to healthcare facilities after repairs without undergoing complete safety testing, specifically failing to receive required flow testing. This recall affects exactly 2 units.

Risk

Without proper flow testing, the pumps may deliver medication or fluids at an incorrect rate. This poses a risk of under-infusion or over-infusion, which could lead to serious medical complications for patients receiving critical care, though no injuries have been reported.

What You Should Do

  1. This recall involves two specific units: a Baxter SIGMA Spectrum Infusion Pump Version 6 (Serial Number 779515, GTIN 00085412091570) and a Version 8 (Serial Number 2153638, GTIN 00085412498683).
  2. Stop using the recalled device immediately. Contact the manufacturer or your distributor to arrange for a return, replacement, or correction of the pump.
  3. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
Model / REF:
35700BAX
Serial Numbers:
779515
GTIN:
00085412091570

Quantity: 1 unit

Product: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
Model / REF:
35700BAX2
Serial Numbers:
2153638
GTIN:
00085412498683

Quantity: 1 unit

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95848
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Healthcare facilities; Hospitals
Manufactured In: United States
Units Affected: 2 products (1 units; 1 unit)
Distributed To: Alabama, Indiana

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 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.