Medical device manufacturer, Kimal, has issued a field safety notice concerning its KFlow Epic Catheter Range. The affected product codes (lot numbers) are KFE-HDL-1219-K (0013009), KFE-HDL-1435-PCK (0013010), KFE-RSDL-1419-K (0013009), KFE-RSDL-1423-K (0013009), KFE-RSDL-1427-K (0013009), and KFE-RHDL-1423.K (0013009).
The above KFlow Epic products may have a discrepancy with the seal of the breather bags. There may be some cases where the breather bag has failed to seal, meaning the product is no longer sterile.
The manufacturer asks users to inspect stock of the above mentioned products and lot numbers. Should they identify that the breather bag is not sealed, users should discontinue use, isolate, label and quarantine any stock to prevent continued use. Product replacement can be arranged.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 24 October 2014