FDAFDA · Food and drugs·Recall number Z-2066-2020
Prismaflex Control Unit
Published May 27, 2020 · Recall initiated: April 7, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- Distribution only to Puerto Rico and Guam
- Lot
- Product Code: 114870; Lot Number: PA18198, PA18199, PA18238, PA22556, PA22558.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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