Home / Recalls / Nico Corp. / Z-2201-2012

Z-2201-2012 Class II Terminated

Recalled by Nico Corp. — Indianapolis, IN

Recall Details

Product Type
Devices
Report Date
August 22, 2012
Initiation Date
July 17, 2012
Termination Date
November 7, 2012
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15 devices (3 boxes, 5 devices per box)

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.

Distribution Pattern

Worldwide Distribution - USA including MI and Canada

Code Information

REF: NN-8012 - LOT: 80345-TD00214 (manufactured on 11-April-2012)

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