Health product recall

Zilver 518 and 635 Biliary Stent (2018-09-26)

Starting date:
September 26, 2018
Posting date:
October 19, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-67954

Affected products

Zilver 518 and 635 Biliary Stent

Reason

This recall is being initiated for specific lots of the the the Zilver 518 Biliary Stent and Zilver 635 Biliary Stent devices. We are initiating a voluntary correction to the instructions for use (IFU) for these stent devices, because the instructions for removing the delivery system following stent deployment are incorrect.

Affected products

Zilver 518 and 635 Biliary Stent

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • ZIB5-125-4.0-20
  • ZIB5-125-4.0-40
  • ZIB5-125-4.0-60
  • ZIB5-125-4.0-80
  • ZIB5-125-5.0-20
  • ZIB5-125-5.0-30
  • ZIB5-125-5.0-40
  • ZIB6-125-12.0-40
  • ZIB6-125-12.0-60
  • ZIB6-125-12.0-80
  • ZIB6-125-14.0-60
  • ZIB6-125-14.0-80
  • ZIB6-125-4.0-80
  • ZIB6-125-5.0-20
  • ZIB6-125-5.0-40
  • ZIB6-125-5.0-60
  • ZIB6-125-5.0-80
  • ZIB6-80-12.0-30
  • ZIB6-80-12.0-40
  • ZIB6-80-12.0-60
  • ZIB6-80-12.0-80
  • ZIB6-80-14.0-40
  • ZIB6-80-14.0-60
  • ZIB6-80-14.0-80
  • ZIB6-80-5.0-20
  • ZIB6-80-5.0-30
  • ZIB6-80-5.0-40
  • ZIB6-80-5.0-60
  • ZIB6-80-5.0-80
Companies
Manufacturer

COOK IRELAND LTD.

O'Halloran Road, National Technological Park

Limerick

IRELAND