ConvaTec recalls Convex Two-Piece Ostomy Skin Barriers (brands: Combihesive Natura Durahesive, SurFit Natura Durahesive, Natura, Varicare) manufactured Feb 2017-Sep 2018 due to off-center starter hole causing potential stoma misalignment.
ConvaTec has received complaints associated with use of convex two-piece skin barriers where the starter hole (stoma hole) is off-center on product manufactured from February 2017 to September 2018. FDA became aware of this problem via routine MDR monitoring.
ConvaTec is recalling certain Convex Two-Piece Ostomy Skin Barriers made between February 2017 and September 2018 because the starter hole (stoma hole) may be off-center. This could lead to improper stoma alignment and complications during use.
The starter hole (stoma hole) may be off-center on products made between February 2017 and September 2018. This could cause improper alignment of the stoma with the skin barrier, potentially leading to leaks, skin irritation, or infection.
People using these ostomy skin barriers for stoma management are affected. Those with existing stomas or who have recently had stoma surgery are at higher risk.
Check for the product names: Combihesive Natura Durahesive, SurFit Natura Durahesive, Natura, or Varicare. Look for the specific product codes and lot numbers listed in the recall notice.
Review the product codes and lot numbers listed in the recall notice to confirm if your item is affected.
ConvaTec has received complaints that the starter hole (stoma hole) is off-center on products manufactured from February 2017 to September 2018, which could cause improper stoma alignment.
The recall notice does not specify a remedy; it only lists affected products and the time frame. Check the product codes and lot numbers to confirm if your item is affected.
The off-center starter hole could lead to improper stoma alignment, potentially causing leaks, skin irritation, or infection.
We’ve drafted a message you can send ConvaTec to request your refund or repair — edit it as you like.
Subject: Recall Z-0233-2020 — ConvaTec ConvaTec Hello, I own a ConvaTec that is covered by recall Z-0233-2020 from ConvaTec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
