FDAFDA · Food and drugs·Recall number Z-2200-2012
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.
Published August 22, 2012 · Recall initiated: July 17, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nico Corp.
- Distributor
- Worldwide Distribution - USA including MI and Canada
- Lot
- REF: NN-8011 - LOT: 80344-TD00214 (manufactured on 11-April-2012)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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