Z-0120-2021 Class I Terminated
FDA device recall Z-0120-2021 was initiated by Baxter Healthcare Corporation on June 30, 2020 and is designated Class I. Reason for recall: Baxter is updating the device IFU for safety communication regarding cleaning practices. The recall status is terminated (terminated April 29, 2024). Affected quantity: 9352 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 28, 2020
- Initiation Date
- June 30, 2020
- Termination Date
- April 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9352 units
Product Description
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
Reason for Recall
Baxter is updating the device IFU for safety communication regarding cleaning practices.
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)
Code Information
Product Code: 35700ABB, All Serial Numbers; GTIN 00085412091570