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