Exact FDA event identifier

Event 62588

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: July 17, 2012
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Nico Corp.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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.

Z-2200-2012

Recall number: Z-2200-2012
Initiated: July 17, 2012
Classification: Class II
Status: Terminated
Recalling firm: Nico Corp.
Quantity: 20 devices (4 boxes, 5 devices per box)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

REF: NN-8011 - LOT: 80344-TD00214 (manufactured on 11-April-2012)

Distribution pattern

Worldwide Distribution - USA including MI and Canada

device · product 2 of 2

13.5 mm x 60 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.

Z-2201-2012

Recall number: Z-2201-2012
Initiated: July 17, 2012
Classification: Class II
Status: Terminated
Recalling firm: Nico Corp.
Quantity: 15 devices (3 boxes, 5 devices per box)