The Recall Desk

FDA (Devices) recall action 62588

Nico Corp. recalled 2 products on 2012-08-22

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2012-08-22
Critical
0
Units
—

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2012-08-22

    Nico BrainPath Sheaths Recalled for Incorrect Length Labeling

    Nico Corp. is recalling 20 BrainPath sheaths because 50mm units were mislabeled as 60mm, creating a risk of improper fit during use.

    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 with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2012-08-22

    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.

    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
    Category
    Distribution
    1 state