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.
Reported: October 23, 2019 Initiated: September 12, 2019 #Z-0124-2020
Product Description
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.
Reason for Recall
There is a potential for a progressive decline in observed ICP readings of the monitor during use.
Details
- Recalling Firm
- Integra LifeSciences Corp.
- Units Affected
- 189
- Distribution
- The products were distributed to the following US states: CA, CO, CT, FL, IN, NY, OK, PA, TX, WI, and WV. The products were distributed to the following foreign countries: Australia, Belgium.
- Location
- Plainsboro, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Integra LifeSciences Corp.. Units affected: 189.
Why was this product recalled? ▼
There is a potential for a progressive decline in observed ICP readings of the monitor during use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 23, 2019. Severity: Moderate. Recall number: Z-0124-2020.
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