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U.S. Department of Health and Human Services

Class 2 Device Recall 13.5 mm x 50 mm BrainPath Sheath

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  Class 2 Device Recall 13.5 mm x 50 mm BrainPath Sheath see related information
Date Initiated by Firm July 17, 2012
Date Posted August 13, 2012
Recall Status1 Terminated 3 on November 07, 2012
Recall Number Z-2200-2012
Recall Event ID 62588
510(K)Number K120691  
Product Classification Retractor, self-retaining, for neurosurgery - Product Code GZT
Product 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.
Code Information REF: NN-8011 - LOT: 80344-TD00214 (manufactured on 11-April-2012)
Recalling Firm/
Nico Corp.
12263 Bridgewater Rd
Indianapolis IN 46256-9428
Manufacturer 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.
FDA Determined
Cause 2
Labeling mix-ups
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.
Quantity in Commerce 20 devices (4 boxes, 5 devices per box)
Distribution Worldwide Distribution - USA including MI and Canada
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GZT and Original Applicant = NICO CORPORATION