FDASeptember 12, 2019device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

integra lifesciencesintegra

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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