Medical device manufacturer, Terumo, has issued a medical device safety alert concerning HARVEST Platelet-Rich Plasma (PRP) Procedure Packs. The details for the affected products are as follows:
The manufacturer has become aware of instances where the Tyvek lid and product label may not match the package contents within some procedure packs. All catalog numbers mentioned above should contain a 30-mL process disposable, however, in some cases they contain a 60-mL process disposable instead. According to the manufacturer, 33 complaints have been reported with this issue and its risk evaluation concluded that there is risk of delayed therapy if no other disposable sets are available within the facility to perform the therapeutic procedure.
The manufacturer advises healthcare providers to inspect and verify the size of the process disposable before starting a procedure. The inspection can be done without fully opening the set for maintaining sterility. According to the manufacturer, only the 30-mL process disposable contain ribs that run vertically along the sides of the cylinder tube chamber. If the process disposable included in a 30-mL set does not contain the ribs, then it may be a 60-mL process disposable.
According to the local supplier, the products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary action.
Posted on 11 May 2021