Events

Recall of INTRADYN TEAR AWAY-SHEATH INTRODUCER SETS W/SPIN-LOCK ADAPTER (SINGLE SET)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by B. BRAUN MEDICAL 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
    115670
  • Event Risk Class
    II
  • Event Initiated Date
    2005-06-08
  • 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
    Cie had reports of a tearaway introducer sheaths with craked hubs/handles and/or improper peeling of the sheath during use in a small percentage of products.

Device

INTRADYN TEAR AWAY-SHEATH INTRODUCER SETS W/SPIN-LOCK ADAPTER (SINGLE SET)
  • Model / Serial
    Model Catalog: (Lot serial: 60734898); Model Catalog: (Lot serial: 60521374); Model Catalog: (Lot serial: 60702179); Model Catalog: (Lot serial: 60722688); Model Catalog: (Lot serial: 60710159); Model Catalog: STA 8 (Lot serial: 60707368); Model Catalog: STA 16 (Lot serial: 60707368); Model Catalog: STA 5 (Lot serial: 60707368); Model Catalog: STA 9 (Lot serial: 60707368); Model Catalog: 610102 (Lot serial: 60707368); Model Catalog: 610152 (Lot serial: 60707368); Model Catalog: 333606 (Lot serial: 60707368); Model Catalog: 610652 (Lot serial: 60707368); Model Catalog: 333615A (Lot serial: 60707368); Model Catalog: 333612 (Lot serial: 60707368); Model Catalog: 333614 (Lot serial: 60707368); Model Catalog: 333603 (Lot serial: 60707368); Model Catalog: 333611 (Lot serial: 60707368); Model Catalog: 333613 (Lot serial: 60707368); Model Catalog: (Lot serial: 60708049); Model Catalog: (Lot serial: 60702094); Model Catalog: (Lot serial: 60551766); Model Catalog: (Lot serial: 60723081); Model Catalog: (Lot
  • Product Description
    INTRADYN TEARAWAY SHEATH INTRODUCER SET
  • Manufacturer
    B. BRAUN MEDICAL INC.

Manufacturer

B. BRAUN MEDICAL INC.