Medical device manufacturer, 3M, has issued a medical device safety alert concerning certain lots of Scotchcast Wet or Dry Cast Padding. The affected catalogue numbers and lot numbers are provided in the following table:-
| Catalogue numbers | Lot numbers |
|---|---|
| WDP2 | 792920, 793090, 793640 & 796078 |
| WDP3 | 792921, 793098, 793638, 796077 & 798487 |
| WDP4 | 792922, 793116, 793637, 796079, & 798488 |
| WDP6 | 792923, 793636, 798489, 799235 & 799236 |
The manufacturer is conducting a voluntary product recall of selected lots of 3M Scotchcast Wet or Dry Cast Padding following a determination that the cast padding material does not consistently repel water. Lack of repellency may result in prolonged cast dry times after exposure to wet conditions. The manufacturer become aware of this issue through health care provider feedback and confirmed it by internal testing. There is a potential of skin maceration under a cast exhibiting inconsistent repellency characteristics. There have been no reports of patient injury associated this material to date.
The manufacturer is advising all affected users that currently at the end user setting the captioned cast padding may be used under dry conditions only until replacement product is available.
According to the local supplier, 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 07 August 2013