Integra LifeSciences Recalls Cerelink ICP Monitor Due to Reading Decline
Integra LifeSciences is recalling 189 Cerelink ICP Monitor units because they may show a progressive decline in intracranial pressure readings during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential for inaccurate readings (progressive decline in ICP), which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Integra LifeSciences Corp. is recalling 189 units of the Cerelink ICP Monitor, Model Number 826820. The device is intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems.
The recall was initiated because there is a potential for a progressive decline in observed intracranial pressure (ICP) readings of the monitor during use. The affected products were distributed to the following US states: CA, CO, CT, FL, IN, NY, OK, PA, TX, WI, and WV. The products were also distributed to the foreign countries of Australia and Belgium.
Healthcare facilities and users should stop using the affected devices and contact Integra LifeSciences Corp. for further instructions on the recall.
The recalled product
- 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.
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 189
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All systems
Distribution
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