ConvaTec Recalls Convex Two-Piece Ostomy Skin Barriers Due to Off-Center Stoma Hole
ConvaTec is recalling convex two-piece ostomy skin barriers manufactured between February 2017 and September 2018 because the stoma hole may be off-center.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect (off-center stoma hole) poses a risk of harm to users by potentially compromising the seal of the ostomy appliance, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
ConvaTec, Inc. is recalling specific lots of Convex Two-Piece Ostomy System (Skin Barrier) products. The affected products are marketed under the brands Combihesive Natura Durahesive, SurFit Natura Durahesive, Natura, and Varicare. The recall covers units manufactured from February 2017 to September 2018.
The recall was initiated after ConvaTec received complaints indicating that the starter hole (stoma hole) on the skin barrier is off-center. The U.S. Food and Drug Administration (FDA) became aware of this issue through routine Medical Device Reporting (MDR) monitoring. The agency has classified this as a Class II recall.
Consumers who have these products should stop using them and contact ConvaTec for instructions on how to return the product or obtain a replacement. The specific lot numbers and product codes affected are listed in the official FDA recall notice.
The recalled product
- Product
- Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2) SurFit Natura Durahesive 3) Natura 4) Varicare Product Usage: stoma management
- Manufacturer
- ConvaTec, Inc
- Category
- Medical Device — Ostomy Supplies
- Affected units
- 8,008,131
Distribution
Distribution scope not specified by the agency.
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