Z-2200-2012Class II

13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized...

Name: Z-2200-2012 13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized...
Creator: Nico Corp.
Published: 2012-07-17
License: https://open.fda.gov/license/

Nico Corporation / initiated 2012-07-17 / Terminated / root cause: labeling and UDI

FDA source

Nico Corp. began a recall of 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... on 2012-07-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2200-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-17
Posted: 2012-08-13
Terminated: 2012-11-07
Recalling firm: Nico Corporation
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.
Product code: GZT Retractor, Self-Retaining, For Neurosurgery
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.
Root cause tag: labeling and UDI
FDA root cause: 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
Product codes and lots: REF: NN-8011 - LOT: 80344-TD00214 (manufactured on 11-April-2012)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2200-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2200-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-13
Z-2201-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-13

Product code GZT

K120691Class IIBrain PortNico Corporation / cleared 2012-06-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)