Medical device manufacturer, Baxter, has issued a field safety notice (FSN) concerning Dura-Guard (Product codes: DG0209SNBIO, DG0404SNBIO, DG0608SNBIO, DG0814SNBIO) and Peri-Guard (Product code: PC0608N).
The manufacturer reminds customers of the approved indications for use for Dura-Guard and Peri-Guard. This notification is being sent due to two recent reports involving use of the incorrect product during surgery.
Dura-Guard has the approved indication for use as a dura substitute for the closure of dura mater during neurosurgery. Peri-Guard is intended for repair of pericardial structures and for use as prosthesis for the surgical repair of soft tissue deficiencies, and it is also intended for use as a patch material for intra-cardiac defects, great vessel, septal defect and annulus repair, and suture-line buttressing.
The manufacturer advises users that only Dura-Guard is indicated for use as a dura substitute. Peri-Guard should not be used as it is not indicated for this type of use. Users can continue to use the concerned products according to their Instructions for Use.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 31 July 2014