Events

Recall of SNAP N PEELAWAY SHEATH AND DILATOR SET

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GYRUS ACMI INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    17945
  • Event Risk Class
    III
  • Event Initiated Date
    2005-07-25
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Acmi received a report from b. braun manufacturer of device that there were cracks in the hub/handle & improper peeling of the shaft were observed. this event is isolated to those lots in this action.

Device

SNAP N PEELAWAY SHEATH AND DILATOR SET
  • Model / Serial
    Model Catalog: 60810BX (Lot serial: 1339994F); Model Catalog: 61012BX (Lot serial: 1339994F); Model Catalog: 60810BX (Lot serial: 1325384E); Model Catalog: 61012BX (Lot serial: 1321584E); Model Catalog: 60810BX (Lot serial: 1321584E); Model Catalog: 61012BX (Lot serial: 1312704E); Model Catalog: 60810BX (Lot serial: 1312704E); Model Catalog: 61012BX (Lot serial: 1297324D); Model Catalog: 60810BX (Lot serial: 1297324D); Model Catalog: 61012BX (Lot serial: 1441195B); Model Catalog: 60810BX (Lot serial: 1441195B); Model Catalog: 61012BX (Lot serial: 1430855B); Model Catalog: 60810BX (Lot serial: 1430855B); Model Catalog: 61012BX (Lot serial: 1427565A); Model Catalog: 60810BX (Lot serial: 1427565A); Model Catalog: 61012BX (Lot serial: 1419235A); Model Catalog: 60810BX (Lot serial: 1419235A); Model Catalog: 61012BX (Lot serial: 1412604M); Model Catalog: 60810BX (Lot serial: 1412604M); Model Catalog: 61012BX (Lot serial: 1383294K); Model Catalog: 60810BX (Lot serial: 1383294K); Model Catalog: 61012BX (Lot serial:
  • Product Description
    ACMI SNAP & PEEL INTRODUCER SHEATHS
  • Manufacturer
    GYRUS ACMI INC.

Manufacturer

GYRUS ACMI INC.