Health product recall

S.M.A.R.T. FLEX BILIARY STENT SYSTEM (2021-10-04)

Starting date:
October 4, 2021
Posting date:
October 15, 2021
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-76659

Last updated:
2021-10-15

Affected Products

S.M.A.R.T. FLEX BILIARY STENT SYSTEM

Reason

This voluntary recall is being conducted because Cordis has identified that the specific lot identified may have had inadequate adhesive applied which could result in distal tip dislodgement / separation.

Affected products

S.M.A.R.T. FLEX BILIARY STENT SYSTEM

Lot or serial number

253349

Model or catalog number

SF09060SB

Companies
Manufacturer

Cordis Cashel

Cahir Road

CASHEL, TIPPERARY

IRELAND