Medical device manufacturer, Ethicon, has issued a medical device safety alert concerning its ENDOLOOP Product Code EH496. This involves all the batches of ENDOLOOP Product Code EH496 manufactured since 2010.
During ongoing stability testing, it was determined the average knot pull tensile strength in some of the batches was below the specification limit. However, the potential safety risks due to such below average knot pull tensile strength are mitigated by the fact that all the individual strands that were tested met the minimum values of knot pull tensile strength.
According to the manufacturer, no complaints related to infection or any wound dehiscence has been reported from the batches manufactured with these casings.
Product recall is on-going.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 April 2016