{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Greensboro", "state": "NC", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "83993", "recalling_firm": "ConvaTec, Inc", "address_1": "7900 Triad Center Dr Ste 400", "address_2": "", "postal_code": "27409-9076", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Telephone", "distribution_pattern": "Worldwide distributions.", "recall_number": "Z-0233-2020", "product_description": "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", "product_quantity": "8,008131 skin barriers", "reason_for_recall": "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.", "recall_initiation_date": "20190906", "center_classification_date": "20191029", "termination_date": "20221130", "report_date": "20191106", "code_info": "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 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7L01338 402207 7K02047 402207 8A00738 402208 7H04930 402208 7J04233 402209 7H03497 402210 7H04918 402211 7H05736 402200 7J01294 402201 7F03877 402201 7H04125 402201 8D01629 402202 7H01478 402202 7K05368 402202 8D05099 402202 8G04010 402203 7J00665 402203 7K03423 402203 7L01062 402203 8C03915 402204 7F00956 402204 7H01474 402204 7K02141 402204 8D05096 402204 8G01613 402204 8H04519 402205 7G03645 402205 7M03576 402205 8D00476 402205 8J00540 402206 7G03647 402206 7L01339 402206 7M03584 402206 8C00953 402206 8C03490 402207 7K02048 402207 8A00737 402207 8F00089 402207 8G03493 402208 7H04929 402208 7J04231 402208 8H00327 402209 7H03495 402209 7H03496 402210 7H04917 402211 7H05737 413177 7C05884 413177 7L03069 413177 8C03530 413178 7C05886 413178 7E02314 413178 7F04002 413178 7M03586 413178 8A00727 413178 8B03741 413178 8F00684 413178 8H04702 413179 7D01169 413179 8A00731 413179 8E04641 413180 7C01423 413180 7C02570 413180 7J01730 413180 7K00522 413180 7K05910 413180 7M02816 413180 8C05312 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404593 8B04381 404593 8C00509 404593 8C01171 404593 8C02729 404593 8C03723 404593 8D02090 404593 8D03559 404593 8E01307 404593 8E02086 404593 8E03031 404593 8E04637 404593 8F02984 404593 8F03648 404593 8F04417 404593 8G00535 404593 8G03022 404593 8G04263 404593 8H01875 404593 8H01908 404593 8H04937 404594 7E01633 404594 7E04176 404594 7E04177 404594 7E04777 404594 7F02063 404594 7F05062 404594 7H04130 404594 7H04920 404594 7J02079 404594 7L04700 404594 7L05271 404594 7M00428 404594 7M01598 404594 7M01995 404594 7M03355 404594 8A00740 404594 8D00463 404594 8D02102 404594 8D02814 404594 8D03557 404594 8E00637 404594 8E01067 404594 8E01627 404594 8E03029 404594 8F03634 404594 8F04925 404594 8G03730 404594 8H01554 404594 8H02438 404594 8H04517 4) Varicare Product Code Lot Number 125278 7J00006 125279 7F04003 125279 7J00008 125279 8F00683 125280 7M03972 125280 8A00733 125280 8E04639 125281 7E01836 125281 7K00524 125282 7J00001 125282 8E03843 125283 7F03154 125283 7M03580 125283 8F01049 125284 7H02190 125285 7J04969 125285 8G03496", "more_code_info": "" } ] }