FDA Device recall Z-2201-2012
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 ob…
- FDA Device
- Class II
- terminated
- Published 2012-08-22
On 2012-08-22 the FDA classified a Class II recall of 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 ob… by Nico, citing 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 packa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2201-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-17 |
| Published | 2012-08-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nico |
| Distribution | MI |
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 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
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.
Identifiers
| code_info | REF: NN-8012 - LOT: 80345-TD00214 (manufactured on 11-April-2012) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2201-2012%22
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