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Recall Observatory FDA recall evidence

Device product

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)

Z-0121-2021

June 30, 2020

Class I

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 86062
Status
Terminated
Classification
Class I
Quantity
310,969 units
Official record key
device-enforcement:Z-0121-2021

Official wording

Reason: Baxter is updating the device IFU for safety communication regarding cleaning practices.

Code information: Product Code: 35700BAX, All Serial Numbers; GTIN 00085412091570

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

    reason.no_named_rule · v1.0.0

    Baxter is updating the device IFU for safety communication regarding cleaning practices.