Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assem

U.S. FDA — Device Enforcement · United States · 2012-07-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2201-2012
Date of alert: 2012-07-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Nico Corp.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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