Medical device manufacturer, Ethicon, has issued a medical device safety alert concerning its HARMONIC ACE+ 7 Shears [Product code: HARH23, HARH36, HARH45].
The manufacturer is initiating a global voluntary recall (removal) of the HARMONIC ACE+ 7 Shears (HARH23, HARH36, HARH45) because under extreme handling circumstances, damage, such as a hole, can occur in the Tyvek lid due to an interaction between the Advanced Hemostasis (green) button and the Tyvek lid which could compromise device sterility.
The manufacturer has received no reports of adverse events for this issue and this recall does not relate to the functionality of the device. Affected users are advised to use alternative product while waiting for replacement.
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 7 October 2015