FDA recall Z-0124-2020

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.

Reason for recall

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

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.

Key facts

Status

Ongoing

Initiation date

2019-09-12

Report date

2019-10-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plainsboro, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0124-2020