Medical device manufacturer, Cook Medical, has issued a medical device safety alert concerning its Torcon NB Advantage Catheter. The affected products distributed in Hong Kong are identified as follow:
The manufacturer has identified that the pouches for the affected lots may be undersealed, potentially compromising the sterility of the product. Potential adverse events that may occur if the affected product is used include increased procedural time to obtain a replacement and local or systemic infection.
According to the manufacturer, the issue is related to the chevron seal, which is a feature of the pouches supplied to the manufacturer. The supplier has initiated an investigation to determine the appropriate corrective action(s) to prevent reoccurrence of a similar issue.
Affected users are advised to examine inventory , quarantine, and immediately cease all distribution and use of the affected product.
Product recall is on-going.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 22 October 2019