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Class I Recall For Integra’s CereLink Intracranial Pressure Monitors

 
• By Brian Bossetta

The US FDA has labelled a June recall of intracranial pressure monitors from Integra with its most serious designation, class I.

Recall
• Source: Shutterstock

In June, Integra LifeSciences initiated a recall of 388 CereLink intracranial pressure monitors (ICPs) because of reports that readings from the devices were inaccurate. The company also adjusted its quarterly and yearly earnings to reflect the impact of the recall. (Also see "Integra Issues Recall Of Intracranial Pressure Monitors" - Medtech Insight, 25 August, 2022.)

The Food and Drug Administration has now labelled that recall as class I.

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