Medical device manufacturer, Oscor Incorporation, has issued a medical device safety alert concerning its Adelante Breezeway 8F and 10F [Model number: AB081041; Lot number (Date of manufacture): C1-12312 (19 Jan 2016), OR-04686 (17 Jul 2015)].

The manufacturer has been made aware of a complaint where a fragment of the sheath inner liner came off during the insertion of the dilator in the preparation of the sheath prior to use.

According to the manufacturer, the reported failure did not cause patient injury; however, the risk for possible injury is a concern if the sheath is not properly flushed and tested with dilator prior to use.

The users are advised to take the following actions:

• Immediately check their inventory to confirm that they do or do not have units from these lot(s) in their possession.
• Identify and set aside any unit from the identified lot in a manner that ensures the affected product will not be used. Check all storage and usage.

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 13 October 2016