13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues.
FDA Recall Z-2200-2012 · Posted 2012-08-13
Advertisement
Recalling FirmNico Corp.
Recall StatusTerminated
Product CodeGZT
Date Initiated2012-07-17
Date Terminated2012-11-07
Product Quantity20 devices (4 boxes, 5 devices per box)
Reason for Recall
BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled
as 60mm. The length callout on the label does not match the actual length of the sheath within the
packaging resulting in an improper fit as further explained below. This mislabeling was
discovered on 29-June-2012 during a clinical case.
Firm Action
NICO Neuro and Spine sent an Urgent Recall letter to all affected customers on July 18, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete the recall response form.
Affected sheaths distributed within the US will be obtained and discarded by NICO. Affected sheaths shipped to Canada will be obtained and discarded by NICOs distributor, Galen Medical.
For questions customers should call 888-632-7071.
Root Cause
Labeling mix-ups
Distribution Pattern
Worldwide Distribution - USA including MI and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement