Nico BrainPath Sheath Recall Due to Incorrect Length Labeling
Nico Corp. is recalling 15 BrainPath sheaths because 50mm units were mislabeled as 60mm, causing improper fit.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score. The hazard involves a labeling error leading to improper fit, but the source text does not report any injuries, illnesses, or fatalities.
Plain-English summary
Nico Corp. is recalling 15 units of the 13.5 mm x 60 mm BrainPath Sheath. The recall involves 3 boxes containing 5 devices each. The specific lot number is 80345-TD00214, manufactured on April 11, 2012. These devices were distributed worldwide, including in the United States (specifically Michigan) and Canada.
The recall was initiated because the sheaths were mislabeled. Units that actually measure 50mm were labeled as 60mm. This discrepancy between the label and the actual physical length of the sheath results in an improper fit when the device is used. The error was discovered on June 29, 2012, during a clinical case.
The BrainPath system consists of reusable obturators and single-patient-use disposable sheaths designed to provide access to neurological tissues. Because the length callout on the label does not match the actual length of the sheath within the packaging, the device may not fit correctly when assembled with the obturator. Users should stop using the affected devices and contact Nico Corp. for instructions on return or replacement.
The recalled product
- 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
- Manufacturer
- Nico Corp.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- REF: NN-8012 - LOT: 80345-TD00214 (manufactured on 11-April-2012)
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Nico Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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