13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is recall: Labeling Error
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…
Why was 13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
REF: NN-8011 - LOT: 80344-TD00214 (manufactured on 11-April-2012)
- Product
- 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…
- Recalling firm
- Nico Corp.
- Quantity
- 20 devices (4 boxes, 5 devices per box)
- Distribution
- Worldwide Distribution - USA including MI and Canada
- Recall date
- August 22, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)