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Recall Observatory FDA recall evidence

Device 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.

Z-0124-2020

September 12, 2019

Class II

Product summary

Firm
Integra LifeSciences Corp.
Event
Event 83831
Status
Ongoing
Classification
Class II
Quantity
189
Official record key
device-enforcement:Z-0124-2020

Official wording

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

Code information: All systems

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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