FDAFDA · Food and drugs·Recall number Z-0121-2021
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
Published October 28, 2020 · Recall initiated: June 30, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Baxter is updating the device IFU for safety communication regarding cleaning practices.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- Distribution throughout the United States, St. Thomas USVI, and Puerto Rico. Foreign distribution including Canada, Caribbean (Barbados, Trinidad and Tobago, Jamaica, Bahamas, Bermuda, and Guyana)
- Lot
- Product Code: 35700BAX, All Serial Numbers; GTIN 00085412091570
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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