MEDRAD INTEGO PET INFUSION SYSTEM - SOURCE ADMINI

Starting date:

October 5, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Identification number:

RA-60678

• Reason
• Affected products

Affected Products

Reason

On November 2015, during a review of historical Intego SAS Testing, it was discovered that documented test evidence related to 85 PSI (Stability Index) for 35 seconds could not be found. When the necessary testing was recently conducted, some failures were found at three year simulated age testing. The failed samples exhibited leaks in the coil bond joint. There was no test failures of the samples at one year accelerated age. Product is currently labeled with a 3 year shelf-life and thus needs to be corrected until this shelf-life can be re- established.

Affected products