Camino 110-4B Olm Intracranial Pressure Mnitoring Kit; Camino 110-4g Post Craniotomy Subdural Pressure Monitoring Kit; C

• • Terminated Z-1815-2015 FDA Class II ·initiated 27 May 2015

  Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Catheters because they may have been incorrectly assembled. Specifically, the o-ring in the bolt adapter may be in the wrong location and as a result, there is a potential CSF/blood could leak from the bolt adapter.

• • Terminated Z-2072-2014 FDA Class II ·initiated 9 Jul 2014 ·on shared 510(k) K102875

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

• • Terminated Z-0117-2014 FDA Class II ·initiated 10 Sep 2013

  Integra LifeSciences has identified through an internal evaluation that in order to comply with US FDA requirements, certain Camino Intracranial Pressure Monitoring Kits require additional labelling to indicate they are UNSAFE in an MR environment. Only the following Camino Intracranial Pressure Monitoring Kits are affected: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K102875 ↗

FDA Product Code

GWM

Models / Variants

Camino 110-4B Olm Intracranial Pressure Mnitoring Kit

Camino 110-4g Post Craniotomy Subdural Pressure Monitoring Kit

C

Device Class

Class II

Regulation

21 CFR Part 882.1620

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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