Medical device manufacturer, Medtronic, has issued a field safety notice concerning certain lots of Endo-Scrub 2 Sheaths and Tubing Set. The affected model numbers are as follows:
The luer connector on the end of the tubing that attaches to the sheath may break off, either prior to or during use. Once the connector breaks, the flow of saline to the sheath either ceases or is reduced and leakage occurs at the fracture site.
The manufacturer advises users to continue using the affected sheaths in stock, and not to scrap or return current Endo-Scrub Sheaths. Furthermore, the manufacturer will provide users with new tubing to have available and to use if users experience a broken luer connector.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 13 March 2014