Prismaflex Control Unit recall
Prismaflex Control Unit
Why was Prismaflex Control Unit recalled?
Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Code: 114870; Lot Number: PA18198, PA18199, PA18238, PA22556, PA22558.
- Product
- Prismaflex Control Unit
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 5 devices US territories
- Distribution
- Distribution only to Puerto Rico and Guam
- Recall date
- May 27, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)