This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
S.M.A.R.T. FLEX BILIARY STENT SYSTEM (2017-11-17)
- Starting date:
- November 17, 2017
- Posting date:
- December 8, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Hospitals, General Public, Healthcare Professionals
- Identification number:
- RA-65330
Affected products
S.M.A.R.T. FLEX BILIARY STENT SYSTEM
Reason
Based on one complaint and the subsequent investigation, Cordis has determined that selected lots of S.M.A.R.T. Flex Biliary Stent System have a potential for cracked Luer hubs, due to a manufacturing error. The Luer hub is used to inject contrast/saline during procedure preparation, prior to insertion of the stent system into the patient. A cracked hub could result in leakage of saline, or in the worst case, inability to flush the outer sheath of the catheter.
Affected products
S.M.A.R.T. FLEX BILIARY STENT SYSTEM
Lot or serial number
40997
41002
41003
41124
41318
41322
41353
41121
Model or catalog number
SF06100MB
SF06120MB
SF09060MB
SF09100SB
SF10040SB
SF10060SB
Companies
- Manufacturer
-
Cordis Cashel
Cahir Road
CASHEL, TIPPERARY
IRELAND