Port-a-Cath II Implantable Venous Access System (2013-09-06)

Starting date:

September 6, 2013

Posting date:

October 28, 2013

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-36431

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  Reason
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  Affected products

Recalled Products

Port-a-Cath II Implantable Venous Access System 

Reason

Since August 2009 Smiths Medical has received a total of 3 complaints regarding the introducer sheath and the introducer opening being too small for the width of the catheter experienced with Port-a-cath and Port-a-cath II implantable venous and arterial access systems and introducer sets. There have been no reports of patient injury or death associated with this issue. Investigation of this issue has identified the root cause to be related to the incorrect size  introducer being used in several lots of finished goods. An in-depth investigation concluded that the incorrect introducer size was limited to 1 component part (from St. Jude Medical), which were put into production of 36 Smiths Medical finished goods lot numbers.

Affected products