Peritoneal Dialysis(PD) Swan Neck Catheters (2014-11-10)

Starting date:

November 10, 2014

Posting date:

December 5, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-42771

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  Reason
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  Affected products

Recalled Products

Peritoneal Dialysis(PD) Swan Neck Catheters

Reason

Medionics has received a few reports of opacification and ballooning of the peritoneal dialysis catheters at the exit-site, however no adverse events have been reported associated with this issue. The age of the implanted catheters in the reported incidents ranged from 30 months to 80 months.

Investigation of these incidents indicates that the structural changes to PD catheters at the exit-site may occur with prolonged use of certain cleansing agents and antibiotic cream or ointment. Additionally, use of solutions containing organic solvents for catheter cleaning may cause the breakdown of silicone tubing. The likelihood of structural changes to silicone PD catheters increases over the duration of implantation.

Affected products