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

Recalled October 23, 2019 · FDA recall Z-0124-2020 · Integra LifeSciences

Hazard

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

Units

189

Sold at

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.

Description

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

Product

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.

Manufacturer(s)

Integra LifeSciences Corp.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →