ConvaTec recalls 10-pack SUR-FIT Natura Moldable Durahesive Skin Barrier (REF 411802) due to incorrect labeling with a different product. Affected units were shipped in Lot 7H02242.
A portion of Lot 7H02242 outer boxes (market units) of the SUR-FIT Natura Moldable Durahesive Skin Barrier (10 pack, 45 mm, REF 411802) were incorrectly labeled as Natura Moldable Stomahesive Skin Barrier (10 pack, 45 mm, REF 411803).
ConvaTec is recalling 10-pack SUR-FIT Natura Moldable Durahesive Skin Barrier products (REF 411802) because some units were incorrectly labeled as a different product. This labeling error means users might be using the wrong product, which could cause confusion or incorrect application.
The product was incorrectly labeled as a different type of skin barrier (Natura Moldable Stomahesive Skin Barrier) in some outer boxes. This labeling error could lead to users applying the wrong product, which might not fit properly or provide the intended protection for ostomy care.
People who own or use the SUR-FIT Natura Moldable Durahesive Skin Barrier (10 pack, 45 mm, REF 411802) from Lot 7H02242 are affected. Those with ostomy care needs are most at risk due to potential confusion with the incorrect product.
Check if your SUR-FIT Natura Moldable Durahesive Skin Barrier (10 pack, 45 mm, REF 411802) was shipped in Lot 7H02242. The incorrect label shows REF 411803 instead of REF 411802.
Look for the product reference code on the outer box: REF 411802 for the correct product or REF 411803 for the incorrectly labeled item.
The recall is due to labeling error, not a safety hazard. The product itself is safe but may be misapplied if the wrong product is used.
Check the outer box for the reference code: REF 411802 is the correct product, while REF 411803 indicates the incorrectly labeled item from Lot 7H02242.
No, the recall is for labeling, not safety. You can continue using the product if it has the correct REF 411802 label.
We’ve drafted a message you can send ConvaTec to request your refund or repair — edit it as you like.
Subject: Recall Z-0525-2018 — ConvaTec ConvaTec Hello, I own a ConvaTec that is covered by recall Z-0525-2018 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.