Reported Aug 3, 2022 · Ongoing
CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
Integra LifeSciences Corp.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. · 1100 Campus Rd · Princeton, NJ · 08540-6650
Is this the product you have?
CereLink ICP MonitorCatalog No. 826820826820P. Intracranial pressure monitor
- Lot codes and dates
- UDI-DI- 10381780533778; All serial numbers.
- Amount recalled
- 1,210 units
Where it was sold
- Nationwide
- GA
Why it was recalled
Stop using this product now
Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message "sensor or extension cable failure!" The firm has found that this is caused by electrical interference from a component of the monitor's circuit board and from the environment.
Using this product could cause serious injury, illness or death — stop using it now.
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