Device product
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
Z-0122-2021
Product summary
- Event
- Event 86062
- Status
- Terminated
- Classification
- Class I
- Quantity
- 152,539 units
- Official record key
device-enforcement:Z-0122-2021
Official wording
Reason: Baxter is updating the device IFU for safety communication regarding cleaning practices.
Code information: Product Code: 35700BAX2, All Serial Numbers; GTIN 00085412498683
Distribution pattern: 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)
Derived failure modes
-
Unknown
Baxter is updating the device IFU for safety communication regarding cleaning practices.