CereLink ICP Monitor recall
CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
Why was CereLink ICP Monitor recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI- 10381780533778; All serial numbers.
- Product
- CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 1,210 units
- Distribution
- Worldwide Distribution: US nationwide, Australia, New Zealand, Canada, Hong Kong, Pakistan, Georgia, Saudi Arabia, Israel, South Africa, United Arab Emirates, Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Portugal, Switzerland, Spain, Sweden, Slovakia, and United Kingdom.
- Recall date
- August 3, 2022
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)