Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Encore 26 Inflation Device Single Pack. The affected products [UPN & Lot numbers] are listed below:-
The manufacturer is implementing a field action on specific lots of Encore 26 Inflation Device single packs. The device trays of certain lots have the potential to crack under certain handling conditions, such as impact during shipment. This issue has been attributed to a change in the material used in the packaging process. The complaints received for this issue have shown that this cracking, which is observed at a low rate (approximately 0.026%), only occurs on one section of the device tray potentially causing a sterile barrier breach.
This field action only affects the single pack Encore 26 Inflation Device. It does not affect Encore Advantage Kits, Encore five (5) packs or other kits containing the Encore device.
Affected users should inspect the device tray. If they identify any units with a cracked tray, they should immediately discontinue use and segregate the affected units in a secure location. If no damage is identified, the device may be used as normal.
Product replacement 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 20 June 2017