Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
Reported: October 28, 2020 Initiated: June 30, 2020 #Z-0121-2021
Product Description
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
Reason for Recall
Baxter is updating the device IFU for safety communication regarding cleaning practices.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 310,969 units
- Distribution
- 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)
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8). Recalled by Baxter Healthcare Corporation. Units affected: 310,969 units.
Why was this product recalled? ▼
Baxter is updating the device IFU for safety communication regarding cleaning practices.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 28, 2020. Severity: Critical. Recall number: Z-0121-2021.
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