Urgent Recall Notice: injeTAK Adjustable Tip Needles
The Society has received information from Endotherapeutics regarding the recall of injeTAK Adjustable Tip Needles.
Endotherapeutics Pty Ltd, after consultation with the Therapeutic Goods Administration (TGA), is conducting a recall of the Laborie Medical Technologies Inc. injeTAK Adjustable Tip Needles. This product is a single-use sterile needle intended to deliver a variety of medicines into tissues during cystoscopic procedures.
Due to a product recall, there is currently a supply issue for the injeTAK Adjustable Tip Needle. This recall was due to a fault with the packaging process; in a small number of cases, a small pinhole could develop during transit which could affect sterility of the product. The issue could impact the sterility of the device, resulting in contamination of the device.
As a result of this issue being identified, Laborie issued a global recall on the majority of stock worldwide. All Australian stock was affected by this recall.
A new shipment of InjeTAK needles is now in transit to Australia. Whilst the size of this shipment is significant, Laborie were not able to supply the full order. The incoming stock will not be sufficient to supply all existing outstanding customer orders, however it is anticipated it will cover approximately 85% of the current unfulfilled orders. As an interim measure, there will be limits on quantities for some larger customers to allow Endotherapeutics to supply as many customers as they can in the short term.
Endotherapeutics expect stock will commence shipping to customers during the week beginning 3rd April (or sooner if the stock is received earlier than planned).
For remaining unfulfilled orders, plus any new orders placed, there will be a further delay until more stock becomes available. Endotherapeutics anticipate rolling periods of backorders over the coming 3 months as worldwide stock levels return to normal. An ETA for the next shipment is not available at this time, however Endotherapeutics are working with Laborie to secure further supply as quickly as possible.
For further information, please download the Urgent Recall Notice.