Recall Z-0124-2020— Integra LifeSciences Corp.

Name: FDA recall Z-0124-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-12

Class II · Ongoing

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2019-09-12. It names one FDA 510(k) clearance: K183406. 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.. Reason: There is a potential for a progressive decline in observed ICP readings of the monitor during use..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Ongoing
Initiated: 2019-09-12
Firm location: Plainsboro, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K183406 — CereLink ICP Monitor, CereLink ICP Extension CableIntegra Lifesciences Corp.·cleared 2019-01-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.