FDAClass IIJune 24, 2015

Integra Camino Intracranial Pressure Monitoring recall

Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L The Camino Intracranial Pressure Monitoring…

Why was Integra Camino Intracranial Pressure Monitoring recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

305000291459, 305000299228, 305000300396, 305000301413, 305000312261, 305000315716, 30500X294240, 30500X304371, 30500X309674, 30500X318076, 3050RX285879, 3050RY297365, 305E00318970, 305E0X320986

Product
Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L The Camino Intracranial Pressure Monitoring…
Recalling firm
Integra LifeSciences Corp.
Quantity
1218 units
Distribution
Worldwide Distribution - US (Nationwide) and Internationally to ARGENTINA, BRAZIL, BULGARIA, CANADA, COLUMBIA, COSTA RICA, FRANCE, GERMANY, ITALY, MEXICO, GERMANY, ITALY, MEXICO, PANAMA, SOUTH AFRICA, SPAIN, SWITZERLAND, UNITED ARAB EMIRATES, AND UNITED KINGDOM
Recall date
June 24, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls