Recall Z-2201-2012— Nico Corp.

Name: FDA recall Z-2201-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-17

Class II · Terminated

Class II FDA medical device recall by Nico Corp., initiated 2012-07-17, terminated 2012-11-07. It names one FDA 510(k) clearance: K120691. Product: 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.. Reason: 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..

Recalling firm: Nico Corp.
Classification: Class II
Status: Terminated
Initiated: 2012-07-17
Terminated: 2012-11-07
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K120691 — BRAIN PORTNico Corporation·cleared 2012-06-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.