FDAClass IIMay 6, 2020

Prismaflex System recall

Prismaflex System, Prismaflex Control Unit

Why was Prismaflex System recalled?

Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.

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:955542; GTIN 07332414124236

Product
Prismaflex System, Prismaflex Control Unit
Recalling firm
Baxter Healthcare Corporation
Quantity
626
Distribution
Distribution in US, Puerto Rico
Recall date
May 6, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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