Medical device manufacturer, Terumo (Philippines) Corporation, has issued a medical device safety alert concerning its Terumo Needle and Terumo Needle Neolus. The products are identified as follow: Terumo Needle and Terumo Needle Neolus
The issue originated from a customer complaint that the manufacturer received claiming that the blister seals are narrow or misaligned. Base on the manufacturer's investigation, it was observed that the sealing portion (width) of the blister package was below the manufacturing standard of 1.5mm and a small opening on the package resulting to seal breach was observed.
According to the manufacturer, the reason for recall is a potential loss of package integrity that may compromise the sterility of the product. There have been no reported patients injuries associated to this issue. No complaints reports have been received regarding infections that may have been associated with the affected products.
The users are requested to identify and confirm if affected products and lot numbers are in their possession, and to quarantine the products.
Product replacement 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 30 January 2019