Medical device manufacturer, Baxter, has issued a field safety notice concerning TISSUE-GUARD Family of Products - VASCU-GUARD, DURA-GUARD, PERI-GUARD and SUPPLE PERI-GUARD. The affected products can be identified as follows:
It has been determined that specific shipping configurations in which more than eight 6 ounce units are shipped together with a specific revision of the Instructions for Use can place pressure on the package, which can lead to damage and leakage. There are no reports of patient involvement or any known adverse events associated with this issue. Improvements to the packing and shipping processes have been implemented to help eliminate this issue.
The manufacturer advises users to discontinue use of the affected products and return them to Baxter for replacement.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 16 October 2013