13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and
FDA device recall Z-2200-2012 · posted 2012-08-13 · Terminated
Recall details
- Recalling firm
- Nico Corp.
- 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.
- Action taken
- NICO Neuro and Spine sent an Urgent Recall letter to all affected customers on July 18, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete the recall response form. Affected sheaths distributed within the US will be obtained and discarded by NICO. Affected sheaths shipped to Canada will be obtained and discarded by NICOs distributor, Galen Medical. For questions customers should call 888-632-7071.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- GZT
- Quantity affected
- 20 devices (4 boxes, 5 devices per box)
- Distribution
- Worldwide Distribution - USA including MI and Canada
- Date initiated
- 2012-07-17
- Date posted
- 2012-08-13
- Date terminated
- 2012-11-07
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRAIN PORT (K120691) | Nico Corporation | 2012-06-05 |