Events

Recall of HEMACAROTID ULTRATHIN KNITTED COLLAGEN COATED VASCULAR PATCH

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BARD CANADA 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
    112321
  • Event Risk Class
    II
  • Event Initiated Date
    2004-01-08
  • 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
    Quality testing performed at the manufacturing facility revealed a slightly higher degree of permeability than that req'd by our specification (5ml/cm2/min @ 120 mm hg).

Device

HEMACAROTID ULTRATHIN KNITTED COLLAGEN COATED VASCULAR PATCH
  • Model / Serial
    Model Catalog: HEK10/150CPUT (Lot serial: 03G21 03J18 03J23); Model Catalog: HEK06/75 CPUT (Lot serial: 03G03 03H08 03J25); Model Catalog: HEK25/100CPUT (Lot serial: 03G21 03J18 03J23); Model Catalog: HEK08/120 CPUT (Lot serial: 03G21 03J18 03J23); Model Catalog: HEK12/75CPUT (Lot serial: 03G21 03J18 03J23); Model Catalog: HEK14/75 CPUT (Lot serial: 03G21 03J18 03J23); Model Catalog: HEK10/75 CPUT (Lot serial: 03G21 03J18 03J23); Model Catalog: HEK08/75 CPUT (Lot serial: 03G21 03J18 03J23); Model Catalog: HEK06/75 CPUT (Lot serial: 03G21 03J18 03J23); Model Catalog: HEK10/150CPUT (Lot serial: 03G24 03J11 03K16); Model Catalog: HEK25/100CPUT (Lot serial: 03G24 03J11 03K16); Model Catalog: HEK08/120 CPUT (Lot serial: 03G24 03J11 03K16); Model Catalog: HEK12/75CPUT (Lot serial: 03G24 03J11 03K16); Model Catalog: HEK14/75 CPUT (Lot serial: 03G24 03J11 03K16); Model Catalog: HEK10/75 CPUT (Lot serial: 03G24 03J11 03K16); Model Catalog: HEK08/75 CPUT (Lot serial: 03G24 03J11 03K16); Model Catalog: HEK06/75 CPUT (L
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.