Reported Oct 23, 2019 · Ongoing
Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type…
Integra LifeSciences Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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. · 311 Enterprise Dr · Plainsboro, NJ · 08536-3344
Is this the product you have?
- 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.
- Lot codes and dates
- All systems
- Amount recalled
- 189
Where it was sold
Why it was recalled
There is a potential for a progressive decline in observed ICP readings of the monitor during use.
This product could cause temporary or reversible health problems — stop using it.
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