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

FDA device recall Z-1815-2015 · posted 2015-06-18 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp.

Reason for recall

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.

Action taken

Integra sent an Urgent Medical Device Recall letter dated May 27, 2015, to all customers who received 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. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to complete the customer response form and return it by email or fax to: FCA3@integralife.com or FAX to 1-609-275-9445. Customers with any questions regarding the instructions are instructed to contact Customer Service at 1-888-601-0203. For questions regarding this recall call 609-936-6822.

Root cause

Under Investigation by firm

Status

Terminated

Product code

GWM

Quantity affected

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,

Date initiated

2015-05-27

Date posted

2015-06-18

Date terminated

2015-12-09

Location

Plainsboro, NJ

Related 510(k) clearances