Z-0712-2021 Class II Ongoing
FDA device recall Z-0712-2021 was initiated by Baxter Healthcare Corporation on Nov 23, 2020 and is designated Class II. Reason for recall: There is a potential software error during programming. The recall status is ongoing. Affected quantity: 9,353 devices.
Recall details
- Product Type
- Devices
- Report Date
- Dec 30, 2020
- Initiation Date
- Nov 23, 2020
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0712-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026