Resource and Education Materials
We would like to notify our Ostomy Product Users of a visually-detectable problem potentially affecting specific convex two-piece skin barriers manufactured from February 2017 to September 2018, where the starter hole (stoma hole) may be off-centre.
- Please refer to Attachment 3 for all affected product which was distributed globally
- Please refer to Appendix A for all affected product which was distributed into Ireland, specifically
The risk of injury is low and is contained to specific lots manufactured over a specific timeframe in the past. Not all product or boxes belonging to the specific lots have this problem. However, since this risk can be visually-detected, we are taking precautionary measures to notify you of this matter so that you can thoroughly check your product to see if it:
- Was manufactured during this period and
- Is visually off-centre.
Example images are provided below:
We are posting this communication to make you aware of the issue and outlining the steps you can take if you identify off-center product at point of use.
- Please examine your inventory. If you have received product that resembles Figure 1 on the left, isolate the affected product and contact the ConvaTec Customer Service Team as listed in Appendix B to arrange for return and replacement of the affected product.
- If you have received product that resembles Figure 2 on the right, no additional action is needed.
- If you are unsure, please contact the ConvaTec Customer Service Team for assistance.
The ConvaTec Customer Service Teams are a group of highly trained product specialists and nurses to help you get the care and information you need throughout your journey as an ostomate.
ConvaTec strives to provide the highest quality products and services to every customer. Our goal is to manufacture products that offer comfort, confidence and security. We want to reassure you that we have addressed the issue on the manufacturing line and corrected product has been distributed into the market.
If you have any further questions or concerns about this notice, please contact Tracey Fairclough at the Amcare Group.
Thank you for being a valued ostomy product user. ConvaTec is passionate about improving people’s lives and we put people at the center of everything we do.