Integra LifeSciences Corp. recalls Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressu…

Recall date

September 12, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0124-2020

FDA classification

Class II

Brand / firm

Integra LifeSciences Corp.

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.