Z-1828-2020 Class II Terminated
FDA device recall Z-1828-2020 was initiated by Baxter Healthcare Corporation on February 6, 2020 and is designated Class II. Reason for recall: Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system. The recall status is terminated (terminated June 1, 2021). Affected quantity: 4946 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2020
- Initiation Date
- February 6, 2020
- Termination Date
- June 1, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4946 units
Product Description
Prismaflex System, Prismaflex Control Unit
Reason for Recall
Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.
Distribution Pattern
Distribution in US, Puerto Rico
Code Information
Product Code: 107493 GTIN 07332414073718