FDAClass IIOctober 23, 2019

Cerelink ICP Monitor recall

Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard…

Why was Cerelink ICP Monitor recalled?

There is a potential for a progressive decline in observed ICP readings of the monitor during use.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

All systems

Product
Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard…
Recalling firm
Integra LifeSciences Corp.
Quantity
189
Distribution
The products were distributed to the following US states: CA, CO, CT, FL, IN, NY, OK, PA, TX, WI, and WV. The products were distributed to the following foreign countries: Australia, Belgium.
Recall date
October 23, 2019
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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