Recall Z-2072-2014— Integra LifeSciences Corp.

Name: FDA recall Z-2072-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-09

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2014-07-09, terminated 2014-10-14. It names one FDA 510(k) clearance: K102875. Product: Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L. Reason: Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR environment..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Terminated
Initiated: 2014-07-09
Terminated: 2014-10-14
Firm location: Plainsboro, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K102875 — CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KITIntegra LifeSciences Corporation·cleared 2010-12-20

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

Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L

Reason for recall

Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR environment.

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