Medical device manufacturer, Pentron Clinical, has issued a medical device safety alert concerning TempSpan CMT [Part no. N69CA].
The manufacturer would also like to inform users that the current Directions for Use (DFU) for TempSpan CMT lists a Working Time Specification that is not indicative of the actual performance of the product.
The current DFU lists the Minimum Working Time as 60 seconds; however, the following timing parameters should be followed when using TempSpan CMT There are no safety or efficacy concerns associated with TempSpan CMT as the product will set.
| Product | TempSpan CMT |
|---|---|
| Minimum Working Time | 45 seconds |
| Maximum Intra Oral Setting Time (from initial mix) | 3 minutes |
According to the manufacturer, the affected products were distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 29 August 2012