Humlebaek, Denmark–based Coloplast issued an urgent field safety notice out of Germany earlier this month to warn users of the packaging issue and instruct them to review stock and return any affected product.
The affected products are Coloplast’s flush ureteric catheters, which are a component of some double loop ureteral stent kits in the Biosoft Duo and Vortek ranges. The polyether block amide devices can be used for inserting guidewire or injecting saline solution or contrast medium.
The company said it issued the recall because there may be some pouches in the affected products’ packaging that could be unsealed, compromising the sterility of the device and potentially leading to infection for the patient.
Since discovering the potential issue, Coloplast has put all relevant inventories on hold and initiated an investigation into the failure.
Earlier this month, the company announced that it decided to keep its interventional urology business — about five months after confirming it was the subject of a strategic review.