Convex Two-Piece Ostomy System (Skin Barrier)
Medical device recall Z-0233-2020. Published in FDA’s Enforcement Report on Nov 6, 2019.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 6, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 8,008131 skin barriers how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
8,008131 skin barriers, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
1) Combihesive Natura Durahesive Product Code Lot Number 404592 7M00630 404592 8A06808 404592 8C04761 404593 7G02852 404593 7L00138 404593 8B05257 404593 8E01304 404593 8E02335 404594 7G05697 404594 7H04921 404594 8A00742 404594 8D00595…
Every code shown here, 1,999 characters
1) Combihesive Natura Durahesive Product Code Lot Number 404592 7M00630 404592 8A06808 404592 8C04761 404593 7G02852 404593 7L00138 404593 8B05257 404593 8E01304 404593 8E02335 404594 7G05697 404594 7H04921 404594 8A00742 404594 8D00595 404594 8E03028 404594 8G03932 125278 7L03070 125278 7L03072 125279 7K05187 125279 8F00670 125279 7E02312 125279 7K05185 125280 7D01173 125280 8A00732 125280 8E04640 125280 7D01171 125280 7D04717 125280 8A00735 125281 7C05398 125281 7K00519 125281 7K05908 125281 8E01678 125281 7C05397 125281 7E01838 125281 7K00520 125281 7L01343 125282 8H01556 125282 7G02896 125282 7M03979 125282 8H01557 125283 7C05414 125283 7M03583 125283 7H04122 125283 7L01045 125283 8J00539 125284 7H02189 125285 7J02058 125285 7D04718 125286 7H06313 125286 8A05991 125286 7F05915 125286 7H06312 125286 7J04227 125287 8A06017 125287 8D05101 125287 8A06018 125287 8D00709 125288 7M00469 125289 7G01364 125289 7K07047 125289 7G01366 125289 7K07046 404592 7F06141 404592 7M00631 404592 8A06810 404592 8E03230 404592 7F06140 404592 7K00745 404592 8A06807 404592 8G02863 404593 7E02405 404593 7F01769 404593 7G02853 404593 7K00530 404593 7G02854 404593 7L00139 404593 7M02490 404593 8B05258 404594 7G05698 404594 7L04697 404594 8A00741 404594 7F05064 404594 7L01034 404594 7M03434 404594 8D05072 404594 8F03571 404594 8H02437 411449 7D05763 411449 7J01296 411449 8E01630 411452 7K03428 411452 8E01631 411452 7D05767 411452 7J01297 411452 7K03432 411452 8E01628 411450 7D02980 411450 7E00892 411450 7L01056 411453 7G01703 411453 7L07676 411453 8E00277 411453 7D02278 411453 7G01705 411453 7L01054 411453 7L07679 411453 7L07681 411453 8J02468 411453 7D03851 411453 7G01989 411453 7L01053 411453 7L07678 411453 8E00276 411451 7G03101 411451 7K01698 411451 7L06598 411451 8F00894 411451 8J01492 411454 7G03114 411454 7J00626 411454 7K01700 411454 7L06599 411454 8E03024 411454 8J01494 411454 7G03113 411454 7J00624 411454 7L06595 411454 8F00893 411454 8J01449 411454 7J02059 411454 7K01699 411454…
FDA’s list runs to 9,808 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distributions.
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 6, 2019.
- FDA classified it on Oct 29, 2019.
- FDA’s Enforcement Report published it on Nov 6, 2019.
- FDA terminated it on Nov 30, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- ConvaTec, Inc, of Greensboro, NC.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Telephone.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 9,808 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.