Z-2066-2020 Class II Terminated
FDA device recall Z-2066-2020 was initiated by Baxter Healthcare Corporation on Apr 7, 2020 and is designated Class II. Reason for recall: Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed. The recall status is terminated (terminated Nov 9, 2021). Affected quantity: 5 devices US territories.
Recall details
- Product Type
- Devices
- Report Date
- May 27, 2020
- Initiation Date
- Apr 7, 2020
- Termination Date
- Nov 9, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 devices US territories
Product description
Prismaflex Control Unit
Reason for recall
Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.
Distribution pattern
Distribution only to Puerto Rico and Guam
Code information
Product Code: 114870; Lot Number: PA18198, PA18199, PA18238, PA22556, PA22558.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2066-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026