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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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 8A00744 411454 8E03025 411454 8F00900 411454 8F04688 411454 7G03112 411454 7J00627 411454 7L06597 411454 8F00891 125030 7G03584 125030 8A02704 125030 8C04243 125030 8F02591 125030 8F04930 125030 7G03586 125030 8A02705 125030 8F04932 125031 8B03228 125031 8B03231 125031 8D05093 125031 7F00605 125031 8B01385 125032 7E03289 125032 7E01290 125032 7F00608 125033 8B04221 125033 8C03752 125033 7E01295 125027 7G00168 125027 7J00670 125027 8C03535 125028 8D00467 125028 8F03145 125028 8G03301 125029 8E01071 125030 8A02706 125030 8F04929 125031 7D03659 125031 7D03959 125031 8B01384 125031 8C00879 125031 8D02694 125031 8E01174 125033 7E01293 125033 8B04220 125034 7E02413 125034 7H04906 125034 8A04957 125034 8B02249 125035 7H04907 125035 7K04884 125035 8B01730 125036 7J03064 125036 8G02097 125037 7L03279 125027 7J00668 125027 8C03534 125028 7L03102 125029 7C05870 125029 7G04446 125029 7J01271 125029 8B01186 125029 8E00349 125030 7C05894 125030 8F02589 125031 7F00603 125031 8B01383 125031 8D02693 125031 8D05092 125032 7E01288 125033 7E01294 125033 8C03753 125034 7E02412 125034 7H04904 125034 8A04958 125035 7H04909 125035 8B01729 125036 8C02095 125037 7L03281 125028 7D00611 125028 8B04996 125028 8F03150 125029 7G04449 125029 8D00470 125029 8E00350 125030 7G03585 125030 8F04927 125031 7F00604 125031 8B03230 125031 8D05081 125032 7E01287 125033 7E01292 125034 7H04905 125034 8A04959 125034 8F02613 125035 7H04910 125035 7K04886 2) SurFit Natura Durahesive Product Code Lot Number 402200 7J01295 402201 7F03878 402201 8A06015 402202 7H01479 402202 7K05366 402202 8G04012 402203 7K03422 402203 7L01060 402203 8C00960 402204 7F00955 402204 7H01475 402204 7K02153 402204 8G01612 402204 8H04521 402205 7F06139 402205 7G03644 402205 8D00474 402205 8G04015 402206 7G03648 402206 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 413180 8E01680 413180 8F00696 413180 8F00901 413181 7B01217 413181 7B04035 413181 7C01401 413181 7C04233 413181 7E01772 413181 7E02668 413181 7E04174 413181 7F01780 413181 7G04454 413181 7K03820 413181 7M03980 413181 8B00893 413181 8E03844 413181 8G00928 413181 8H01558 413181 8H03658 413181 8H04303 413182 7C05415 413182 7D01141 413182 7F03152 413182 7H04051 413182 7L06593 413182 8F01050 413182 8J00537 413183 7B04470 413183 7F01265 413183 7H02188 413183 8A02999 413183 8B03435 413183 8B05002 413183 8C03533 413183 8D05105 413183 8F03646 413184 7C05888 413184 7C06118 413184 7F01763 413184 7J05042 413184 8G03497 413185 7C05891 413185 7C06116 413185 7D04719 413185 7F05916 413185 7H06315 413185 8A04962 413185 8A06014 413185 8C03676 413185 8E01297 413185 8F04684 413185 8G02137 413186 7F05917 413186 8A01385 413186 8D00499 413186 8D05103 413187 7F00550 413187 7H04926 413187 7H05499 413187 7M00471 413187 8B02277 413187 8B03309 413187 8D02868 413187 8F01515 413187 8J02475 413188 7E02407 413188 7G01362 413188 7J00631 413188 8B01726 413188 8D00097 413188 8H00324 413188 8J00420 411449 7D05766 411449 7K03430 411450 7D03850 411450 7G01988 411450 7L07677 411450 8J02466 125026 8A06575 125026 8A06576 125027 7G00162 125027 7G00167 125027 7G00169 125027 7J00669 125028 7L02965 125028 8A00729 125028 8D00468 125028 8F03146 125028 7D00643 125028 7L02964 125028 8D00466 125028 7D00610 125028 8A00728 125028 8B04995 125028 8D00465 125028 8F03149 125028 7D00609 125028 7L02963 125028 8B04997 125028 8F03151 125028 8G03332 125029 8B01190 125029 7J01269 125029 8E00992 125029 7G04445 125029 7J01292 125029 8D00472 125029 8E00347 125029 7C05871 125029 7G04448 125029 7J01270 125029 8D00471 125030 8C04244 125030 8F02590 125030 8F04928 125031 7C04211 125031 7D01175 125031 7F00606 125031 8B03229 125031 8C00877 125031 8E01175 125032 7C04224 125032 7E01289 125033 7E03364 125033 8B04219 125034 7H05074 125034 8F02600 125034 8A04956 125034 8F02614 125035 7H04908 125035 7K04883 125035 7K04885 125036 7J03062 125036 8C02094 125036 7J03065 125037 7L03280 125037 7L03278 125037 7M02850 411451 7G03115 411451 7K01486 411451 8A00745 411451 8E03026 411451 8F00895 411451 8F04686 411451 8J01450 3) Natura Product Code Lot Number 404592 7K00746 404592 7M03042 404592 8A04344 404592 8E03231 404594 7F00003 404594 7G00578 404594 7L01035 404594 7M03432 404594 8B03275 404594 8D05074 404594 8G03296 404594 8J00972 413177 7L03068 413178 7E02270 413178 8A00726 413180 7K00521 413180 7K05907 413180 8F00698 413181 7E01710 413181 7G00166 413181 7M03981 413181 8G00927 413181 8H04356 413182 7F03155 413182 7L01044 413182 8B03860 413182 8F01047 413184 7J04970 413184 8G03499 413185 7H06314 413185 7J04230 413186 8D05102 413187 7M00470 413188 7G01525 413188 7K07045 125278 7L03067 125279 7E02269 125279 7K05186 125279 8F00671 125281 7E01837 125281 7K05911 125281 7L01342 125282 7E01711 125282 7F01779 125282 7G00165 125282 8B00892 125282 8E03842 125283 7F03153 125283 7L01043 125283 7M03582 125284 8C03529 125285 7F01762 125285 8G03495 125286 7H06316 125286 7J04228 125286 8E01296 125287 8A06019 125288 7H04927 125288 7M00468 125289 7G01363 125289 7J00630 420233 7J04280 420233 7J06070 420233 7M03041 420233 8C04758 420233 8E03322 420233 8E05050 404593 7E02404 404593 7G04435 404593 7K04911 404593 8E01305 404593 8G03023 420234 7F01770 420234 7G03384 420234 7G04437 420234 7K00529 420234 7L00137 420234 7M01882 420235 7F00002 420235 7F05063 420235 7J02080 420235 7K02855 420235 7L04696 420235 7M03433 420235 8A00739 420235 8B04155 420235 8C00709 420235 8D02104 420235 8D05073 420235 8F03632 420235 8G03297 420235 8J00971 404592 7C05400 404592 7C05401 404592 7M00632 404592 7M03044 404592 8A00115 404592 8A03532 404592 8A04345 404592 8A04652 404592 8A06020 404592 8C00510 404592 8C02727 404592 8C04760 404592 8D00831 404592 8E03229 404592 8E05049 404593 7D00656 404593 7D04454 404593 7G02078 404593 7G04441 404593 7H02557 404593 7J01301 404593 7K04909 404593 7M01936 404593 8A00074 404593 8B00644 404593 8B02183 404593 8B03434 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- ConvaTec, Inc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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 Codes/Lot Numbers:
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 8A00744 411454 8E03025 411454 8F00900 411454 8F04688 411454 7G03112 411454 7J00627 411454 7L06597 411454 8F00891 125030 7G03584 125030 8A02704 125030 8C04243 125030 8F02591 125030 8F04930 125030 7G03586 125030 8A02705 125030 8F04932 125031 8B03228 125031 8B03231 125031 8D05093 125031 7F00605 125031 8B01385 125032 7E03289 125032 7E01290 125032 7F00608 125033 8B04221 125033 8C03752 125033 7E01295 125027 7G00168 125027 7J00670 125027 8C03535 125028 8D00467 125028 8F03145 125028 8G03301 125029 8E01071 125030 8A02706 125030 8F04929 125031 7D03659 125031 7D03959 125031 8B01384 125031 8C00879 125031 8D02694 125031 8E01174 125033 7E01293 125033 8B04220 125034 7E02413 125034 7H04906 125034 8A04957 125034 8B02249 125035 7H04907 125035 7K04884 125035 8B01730 125036 7J03064 125036 8G02097 125037 7L03279 125027 7J00668 125027 8C03534 125028 7L03102 125029 7C05870 125029 7G04446 125029 7J01271 125029 8B01186 125029 8E00349 125030 7C05894 125030 8F02589 125031 7F00603 125031 8B01383 125031 8D02693 125031 8D05092 125032 7E01288 125033 7E01294 125033 8C03753 125034 7E02412 125034 7H04904 125034 8A04958 125035 7H04909 125035 8B01729 125036 8C02095 125037 7L03281 125028 7D00611 125028 8B04996 125028 8F03150 125029 7G04449 125029 8D00470 125029 8E00350 125030 7G03585 125030 8F04927 125031 7F00604 125031 8B03230 125031 8D05081 125032 7E01287 125033 7E01292 125034 7H04905 125034 8A04959 125034 8F02613 125035 7H04910 125035 7K04886 2) SurFit Natura Durahesive Product Code Lot Number 402200 7J01295 402201 7F03878 402201 8A06015 402202 7H01479 402202 7K05366 402202 8G04012 402203 7K03422 402203 7L01060 402203 8C00960 402204 7F00955 402204 7H01475 402204 7K02153 402204 8G01612 402204 8H04521 402205 7F06139 402205 7G03644 402205 8D00474 402205 8G04015 402206 7G03648 402206 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 413180 8E01680 413180 8F00696 413180 8F00901 413181 7B01217 413181 7B04035 413181 7C01401 413181 7C04233 413181 7E01772 413181 7E02668 413181 7E04174 413181 7F01780 413181 7G04454 413181 7K03820 413181 7M03980 413181 8B00893 413181 8E03844 413181 8G00928 413181 8H01558 413181 8H03658 413181 8H04303 413182 7C05415 413182 7D01141 413182 7F03152 413182 7H04051 413182 7L06593 413182 8F01050 413182 8J00537 413183 7B04470 413183 7F01265 413183 7H02188 413183 8A02999 413183 8B03435 413183 8B05002 413183 8C03533 413183 8D05105 413183 8F03646 413184 7C05888 413184 7C06118 413184 7F01763 413184 7J05042 413184 8G03497 413185 7C05891 413185 7C06116 413185 7D04719 413185 7F05916 413185 7H06315 413185 8A04962 413185 8A06014 413185 8C03676 413185 8E01297 413185 8F04684 413185 8G02137 413186 7F05917 413186 8A01385 413186 8D00499 413186 8D05103 413187 7F00550 413187 7H04926 413187 7H05499 413187 7M00471 413187 8B02277 413187 8B03309 413187 8D02868 413187 8F01515 413187 8J02475 413188 7E02407 413188 7G01362 413188 7J00631 413188 8B01726 413188 8D00097 413188 8H00324 413188 8J00420 411449 7D05766 411449 7K03430 411450 7D03850 411450 7G01988 411450 7L07677 411450 8J02466 125026 8A06575 125026 8A06576 125027 7G00162 125027 7G00167 125027 7G00169 125027 7J00669 125028 7L02965 125028 8A00729 125028 8D00468 125028 8F03146 125028 7D00643 125028 7L02964 125028 8D00466 125028 7D00610 125028 8A00728 125028 8B04995 125028 8D00465 125028 8F03149 125028 7D00609 125028 7L02963 125028 8B04997 125028 8F03151 125028 8G03332 125029 8B01190 125029 7J01269 125029 8E00992 125029 7G04445 125029 7J01292 125029 8D00472 125029 8E00347 125029 7C05871 125029 7G04448 125029 7J01270 125029 8D00471 125030 8C04244 125030 8F02590 125030 8F04928 125031 7C04211 125031 7D01175 125031 7F00606 125031 8B03229 125031 8C00877 125031 8E01175 125032 7C04224 125032 7E01289 125033 7E03364 125033 8B04219 125034 7H05074 125034 8F02600 125034 8A04956 125034 8F02614 125035 7H04908 125035 7K04883 125035 7K04885 125036 7J03062 125036 8C02094 125036 7J03065 125037 7L03280 125037 7L03278 125037 7M02850 411451 7G03115 411451 7K01486 411451 8A00745 411451 8E03026 411451 8F00895 411451 8F04686 411451 8J01450 3) Natura Product Code Lot Number 404592 7K00746 404592 7M03042 404592 8A04344 404592 8E03231 404594 7F00003 404594 7G00578 404594 7L01035 404594 7M03432 404594 8B03275 404594 8D05074 404594 8G03296 404594 8J00972 413177 7L03068 413178 7E02270 413178 8A00726 413180 7K00521 413180 7K05907 413180 8F00698 413181 7E01710 413181 7G00166 413181 7M03981 413181 8G00927 413181 8H04356 413182 7F03155 413182 7L01044 413182 8B03860 413182 8F01047 413184 7J04970 413184 8G03499 413185 7H06314 413185 7J04230 413186 8D05102 413187 7M00470 413188 7G01525 413188 7K07045 125278 7L03067 125279 7E02269 125279 7K05186 125279 8F00671 125281 7E01837 125281 7K05911 125281 7L01342 125282 7E01711 125282 7F01779 125282 7G00165 125282 8B00892 125282 8E03842 125283 7F03153 125283 7L01043 125283 7M03582 125284 8C03529 125285 7F01762 125285 8G03495 125286 7H06316 125286 7J04228 125286 8E01296 125287 8A06019 125288 7H04927 125288 7M00468 125289 7G01363 125289 7J00630 420233 7J04280 420233 7J06070 420233 7M03041 420233 8C04758 420233 8E03322 420233 8E05050 404593 7E02404 404593 7G04435 404593 7K04911 404593 8E01305 404593 8G03023 420234 7F01770 420234 7G03384 420234 7G04437 420234 7K00529 420234 7L00137 420234 7M01882 420235 7F00002 420235 7F05063 420235 7J02080 420235 7K02855 420235 7L04696 420235 7M03433 420235 8A00739 420235 8B04155 420235 8C00709 420235 8D02104 420235 8D05073 420235 8F03632 420235 8G03297 420235 8J00971 404592 7C05400 404592 7C05401 404592 7M00632 404592 7M03044 404592 8A00115 404592 8A03532 404592 8A04345 404592 8A04652 404592 8A06020 404592 8C00510 404592 8C02727 404592 8C04760 404592 8D00831 404592 8E03229 404592 8E05049 404593 7D00656 404593 7D04454 404593 7G02078 404593 7G04441 404593 7H02557 404593 7J01301 404593 7K04909 404593 7M01936 404593 8A00074 404593 8B00644 404593 8B02183 404593 8B03434 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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0233-2020
Related Recalls
Wound dressing may have foreign matter on the product.
Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling. If pre-cut wafers are too big the device cannot be used and if the pre-cut wafer is too small and the device user tries to apply, this could cause abrasion, stomal cut, and bleeding
The product does not meet sterility assurance level.