Prismaflex Control Unit
Reported: May 27, 2020 Initiated: April 7, 2020 #Z-2066-2020
Product Description
Prismaflex Control Unit
Reason for Recall
Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 5 devices US territories
- Distribution
- Distribution only to Puerto Rico and Guam
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Prismaflex Control Unit. Recalled by Baxter Healthcare Corporation. Units affected: 5 devices US territories.
Why was this product recalled? ▼
Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 27, 2020. Severity: Moderate. Recall number: Z-2066-2020.
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