Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
Class I - DangerousWhat Should You Do?
- Check if you have this product: 14,362 Serial Numbers (please contact CDRH for list of affected Serial Numbers).
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Baxter Healthcare Corporation
- Reason for Recall:
- SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly that may cause a Sharp Watchdog Timeout error message. Specifically, the software anomaly causes the error message only under conditions in which a message is being written to the Spectrum Infusion Pumps Event History Log (EHL), and the length of that message exactly matches the size of the available memory at the end of a memory sector. For this reason, the issue is significantly more likely to manifest when poor network maintenance results in high volumes of messages being written to the EHL.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
Product Codes/Lot Numbers:
14,362 Serial Numbers (please contact CDRH for list of affected Serial Numbers).
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1693-2017
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