Recall Z-1395-2022— Integra LifeSciences Corp.

Name: FDA recall Z-1395-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-22

Class I · Ongoing

Class I FDA medical device recall by Integra LifeSciences Corp., initiated 2022-06-22. It names one FDA 510(k) clearance: K210993. Product: CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.. Reason: 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..

Recalling firm: Integra LifeSciences Corp.
Classification: Class I
Status: Ongoing
Initiated: 2022-06-22
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K210993 — CereLink ICP MonitorIntegra Lifesciences Production Corporation·cleared 2021-04-30

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; Catalog No. 826820, 826820P. Intracranial pressure monitor.

Reason for recall

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.

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