Medical device manufacturer, Hospira, has issued a medical device safety alert concerning its Nonvented Y-set for transurethral resection (List number: 06543-01). The impacted batches are 13106NS, 13170NS, 13251NS, 14261NS, 14262NS, 15139NS, 16117NS, 17131NS, 17132NS, 17184NS, 18110NS, 18111NS, 18182NS, 19133NS, 20122NS, 20123NS, 20124NS, 20205NS, 22146NS, 22147NS, 22148NS, 22149NS, 23103NS, 23104NS, 23105NS, 23106NS, 24156NS, 25130NS, 25131NS, 27109NS, 27253NS, 27286NS, 28136NS, 28137NS, 29094NS, 29095NS, 29096NS, 30194NS, 30195NS, 30196NS, 31042NS, 31043NS, 32229NS, 32230NS, 33138NS, 33139NS, 33140NS, 34286NS and 35117NS.
In the complaint review, the manufacturer has discovered the issue of incomplete sealing in the secondary package of the affected batches of devices. The issue occurred either because the sterile pack was not sealed properly or the Tyvek cover sheet was not centered on the bottom tray of the pack, allowing openings at the edge of the sterile package.
The open packaging of the affected product may lead to loss of product sterility, delay in initiating therapy, introduction of infectious agent and particulate onto the surface of the irrigation set. Up to date, the manufacturer did not receive any complaint or adverse reporting associated with the incomplete sealing of the package.
The manufacturer advises affected users not to use the package if it is not intact.
According to the manufacturer, the affected products were distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 17 April 2014