Medical device manufacturer, Teleflex, has issued a medical device safety alert concerning its Arrow OnControl Bone Lesion Biopsy System Tray [Product code: 9464-VC-006, 9464-EU-001, Lot number: 39647326, 39647327, 39647328, 40422734, 40422735, 40808740].
The manufacturer is initiating a medical safety alert for the above-mentioned products due to customers reporting difficulty in inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy sample from being collected. According to the manufacturer, use of a defective device is likely to require immediate repeat biopsy, leading to a prolonged procedure but long-term health consequences are not known.
The manufacturer recommends affected users to check their inventory for product within the scope of this medical safety alert. They should stop using and distributing the impacted products and quarantine them immediately. The manufacturer will organise replacement for unused trays.
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 March 2021