Z-0712-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2020
- Initiation Date
- November 23, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,353 devices
Product Description
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
Reason for Recall
There is a potential software error during programming.
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.
Code Information
Product Code 35700ABB, GTIN 00085412091570