{"recall":{"id":"fda-device-99710","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Cardinal Health 200, LLC recalls 2 products","firm":"Cardinal Health 200, LLC","date":"2026-08-10","reported":"2026-09-30","status":"Ongoing","classification":"Class II","products":[{"name":"Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU ADMIT NEW HAN , Catalog Number: BA1DH0116B; 3) KIT, PRE PROCEDURE , Catalog Number: IVSJV8302E; 4) KIT, IV SUPPLIES , Catalog Number: IVS3223531; 5) KIT, IV SUPPLIES , Catalog Number: IVS3223532; 6) KIT, IV SUPPLIES , Catalog Number: IVS3223533; 7) KIT, IV SUPPLIES , Catalog Number: IVS3223534; 8) KIT, IV SUPPLIES , Catalog Number: IVS3223535; 9) KIT, IV SUPPLIES , Catalog Number: IVS322358M; 10) KIT, IV SUPPLIES , Catalog Number: IVS322358N; 11) KIT, IV SUPPLIES , Catalog Number: IVS322358O; 12) KIT, PATIENT ADMISSIONS , Catalog Number: AMN333032A; 13) KIT, C SECTION , Catalog Number: MAT42267AL; 14) KIT, C SECTION , Catalog Number: MAT4226725; 15) KIT, VAGINAL DELIVERY , Catalog Number: MAT422677G; 16) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226792; 17) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226793; 18) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226794; 19) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226795","code":"1) AMN548616A, UDI-DI: 10197106721834(each), 10197106721834(case), Lot Number: 4249818 ; 2) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5124984 ; 3) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5129488 ; 4) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5129488 ; 5) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5188103 ; 6) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5188103 ; 7) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5211212 ; 8) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5155824 ; 9) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5211985 ; 10) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5279226 ; 11) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5155824 ; 12) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5188103 ; 13) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5211212 ; 14) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5246952 ; 15) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5279226 ; 16) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5279226 ; 17) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 6062168 ; 18) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5155824 ; 19) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5279226 ; 20) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 6062168 ; 21) BA1DH0116B, UDI-DI: 0(each), 0(case), Lot Number: 6051588 ; 22) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5124984 ; 23) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5124984 ; 24) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488 ; 25) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5124984 ; 26) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488 ; 27) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488 ; 28) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5188103 ; 29) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5195818 ; 30) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211907 ; 31) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211985 ; 32) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211212 ; 33) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211985 ; 34) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5279226 ; 35) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488 ; 36) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211985 ; 37) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 6037918 ; 38) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488 ; 39) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5155824 ; 40) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5279226 ; 41) IVS3223531, UDI-DI: 10198956173941(each), 10198956173941(case), Lot Number: 5124984 ; 42) IVS3223532, UDI-DI: 10198956173958(each), 10198956173958(case), Lot Number: 5124984 ; 43) IVS3223533, UDI-DI: 10198956362536(each), 10198956362536(case), Lot Number: 5188103 ; 44) IVS3223533, UDI-DI: 10198956362536(each), 10198956362536(case), Lot Number: 5211985 ; 45) IVS3223534, UDI-DI: 10198956470347(each), 10198956470347(case), Lot Number: 5129488 ; 46) IVS3223534, UDI-DI: 10198956470347(each), 10198956470347(case), Lot Number: 5155824 ; 47) IVS3223534, UDI-DI: 10198956470347(each), 10198956470347(case), Lot Number: 5310701 ; 48) IVS3223535, UDI-DI: 10198956527010(each), 10198956527010(case), Lot Number: 5188103 ; 49) IVS3223535, UDI-DI: 10198956527010(each), 10198956527010(case), Lot Number: 60622168 ; 50) IVS322358M, UDI-DI: 10195594809362(each), 10195594809362(case), Lot Number: 4249818 ; 51) IVS322358M, UDI-DI: 10195594809362(each), 10195594809362(case), Lot Number: 4248961 ; 52) IVS322358M, UDI-DI: 10195594809362(each), 10195594809362(case), Lot Number: 4249818 ; 53) IVS322358M, UDI-DI: 10195594809362(each), 10195594809362(case), Lot Number: 4249818 ; 54) IVS322358M, UDI-DI: 10195594809362(each), 10195594809362(case), Lot Number: 4249818 ; 55) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5124984 ; 56) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 4249818 ; 57) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5124984 ; 58) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5129488 ; 59) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5188103 ; 60) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5188103 ; 61) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5195818 ; 62) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5188103 ; 63) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5188103 ; 64) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5129488 ; 65) IVS322358O, UDI-DI: 10198956517073(each), 10198956517073(case), Lot Number: 6051588 ; 66) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5248375 ; 67) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5309623 ; 68) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5309623 ; 69) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5310701 ; 70) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 6051588 ; 71) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5150160 ; 72) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5188102 ; 73) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5188103 ; 74) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5350797 ; 75) MAT42267AL, UDI-DI: 10198956120129(each), 10198956120129(case), Lot Number: 5126398 ; 76) MAT42267AL, UDI-DI: 10198956120129(each), 10198956120129(case), Lot Number: 5126398 ; 77) MAT42267AL, UDI-DI: 10198956120129(each), 10198956120129(case), Lot Number: 5181074 ; 78) MAT42267AL, UDI-DI: 10198956120129(each), 10198956120129(case), Lot Number: 5188102 ; 79) MAT42267AL, UDI-DI: 10198956120129(each), 10198956120129(case), Lot Number: 5188102 ; 80) MAT42267AL, UDI-DI: 5276968 (each), 10198956120129(case), Lot Number: 10198956120129; 81) MAT4226725, UDI-DI: 5126398 (each), 10198956181557(case), Lot Number: 10198956181557; 82) MAT422677G, UDI-DI: 10198956120136(each), 10198956120136(case), Lot Number: 5126398 ; 83) MAT422677G, UDI-DI: 10198956120136(each), 10198956120136(case), Lot Number: 5126398 ; 84) MAT422677G, UDI-DI: 10198956120136(each), 10198956120136(case), Lot Number: 5129058 ; 85) MAT422677G, UDI-DI: 10198956120136(each), 10198956120136(case), Lot Number: 5126398 ; 86) MAT422677G, UDI-DI: 10198956120136(each), 10198956120136(case), Lot Number: 5210853 ; 87) MAT4226792, UDI-DI: 10198956207974(each), 10198956207974(case), Lot Number: 5129058 ; 88) MAT4226793, UDI-DI: 10198956426405(each), 10198956426405(case), Lot Number: 5350797 ; 89) MAT4226794, UDI-DI: 10198956484559(each), 10198956484559(case), Lot Number: 5309623 ; 90) MAT4226794, UDI-DI: 10198956484559(each), 10198956484559(case), Lot Number: 5310701 ; 91) MAT4226795, UDI-DI: 10198956538023(each), 10198956538023(case), Lot Number: 6051588","quantity":"17503 kits","number":"Z-3254-2026","classification":"Class II"},{"name":"Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalog Number: PVMHIVM15","code":"1) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 20 ; 2) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5126398 ; 3) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5126398 ; 4) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5129488 ; 5) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5181074 ; 6) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5181074 ; 7) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5182660 ; 8) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5188103 ; 9) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5126398 ; 10) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5181074 ; 11) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5188103 ; 12) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5188102 ; 13) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5199118 ; 14) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5188103 ; 15) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5195818 ; 16) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5150160 ; 17) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5195818 ; 18) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5210853 ; 19) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5248375 ; 20) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5276968 ; 21) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5350797 ; 22) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5279226 ; 23) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5350797 ; 24) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5307185 ; 25) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5310701 ; 26) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 6051588 ; 27) PVMHIVM14, UDI-DI: 10198956165434(each), 50198956165432(case), Lot Number: 5126398 ; 28) PVMHIVM15, UDI-DI: 10198956184459(each), 50198956184457(case), Lot Number: 5129058","quantity":"9480 kits","number":"Z-3255-2026","classification":"Class II"}],"reason":"The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or soft tissue infection. Less commonly, systemic infection or other infectious complications may occur.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of FL, KY, MO, NC, OH, TX.","nationwide":true,"states":[],"units":"17503 kits; 9480 kits","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99710","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"ed086344b5b7b9eb","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99710","record":[{"status":"Ongoing","city":"Waukegan","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99710","recalling_firm":"Cardinal Health 200, LLC","address_1":"3651 Birchwood Dr","address_2":"","postal_code":"60085-8337","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of FL, KY, MO, NC, OH, TX.","recall_number":"Z-3254-2026","product_description":"Presource Convenience Kits:  1) KIT, PRE OP                   , Catalog Number: AMN548616A;   2) KIT, NICU ADMIT NEW HAN       , Catalog Number: BA1DH0116B;   3) KIT, PRE PROCEDURE            , Catalog Number: IVSJV8302E;   4) KIT, IV SUPPLIES              , Catalog Number: IVS3223531;   5) KIT, IV SUPPLIES              , Catalog Number: IVS3223532;   6) KIT, IV SUPPLIES              , Catalog Number: IVS3223533;   7) KIT, IV SUPPLIES              , Catalog Number: IVS3223534;   8) KIT, IV SUPPLIES              , Catalog Number: IVS3223535;   9) KIT, IV SUPPLIES              , Catalog Number: IVS322358M;   10) KIT, IV SUPPLIES              , Catalog Number: IVS322358N;   11) KIT, IV SUPPLIES              , Catalog Number: IVS322358O;   12) KIT, PATIENT ADMISSIONS       , Catalog Number: AMN333032A;   13) KIT, C SECTION                , Catalog Number: MAT42267AL;   14) KIT, C SECTION                , Catalog Number: MAT4226725;   15) KIT, VAGINAL DELIVERY         , Catalog Number: MAT422677G;   16) KIT, VAGINAL DELIVERY         , Catalog Number: MAT4226792;   17) KIT, VAGINAL DELIVERY         , Catalog Number: MAT4226793;   18) KIT, VAGINAL DELIVERY         , Catalog Number: MAT4226794;   19) KIT, VAGINAL DELIVERY         , Catalog Number: MAT4226795","product_quantity":"17503 kits","reason_for_recall":"The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or soft tissue infection. Less commonly, systemic infection or other infectious complications may occur.","recall_initiation_date":"20260810","center_classification_date":"20260922","report_date":"20260930","code_info":"1) AMN548616A, UDI-DI: 10197106721834(each), 10197106721834(case), Lot Number: 4249818                       ; 2) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5124984                       ; 3) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5129488                       ; 4) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5129488                       ; 5) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5188103                       ; 6) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5188103                       ; 7) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5211212                       ; 8) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5155824                       ; 9) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5211985                       ; 10) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5279226                       ; 11) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5155824                       ; 12) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5188103                       ; 13) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5211212                       ; 14) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5246952                       ; 15) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5279226                       ; 16) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5279226                       ; 17) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 6062168                       ; 18) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5155824                       ; 19) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5279226                       ; 20) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 6062168                       ; 21) BA1DH0116B, UDI-DI: 0(each), 0(case), Lot Number: 6051588                       ; 22) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5124984                       ; 23) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5124984                       ; 24) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488                       ; 25) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5124984                       ; 26) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488                       ; 27) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488                       ; 28) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5188103                       ; 29) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5195818                       ; 30) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211907                       ; 31) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211985                       ; 32) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211212                       ; 33) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211985                       ; 34) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5279226                       ; 35) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488                       ; 36) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211985                       ; 37) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 6037918                       ; 38) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488                       ; 39) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5155824                       ; 40) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5279226                       ; 41) IVS3223531, UDI-DI: 10198956173941(each), 10198956173941(case), Lot Number: 5124984                       ; 42) IVS3223532, UDI-DI: 10198956173958(each), 10198956173958(case), Lot Number: 5124984                       ; 43) IVS3223533, UDI-DI: 10198956362536(each), 10198956362536(case), Lot Number: 5188103                       ; 44) IVS3223533, UDI-DI: 10198956362536(each), 10198956362536(case), Lot Number: 5211985                       ; 45) IVS3223534, UDI-DI: 10198956470347(each), 10198956470347(case), Lot Number: 5129488                       ; 46) IVS3223534, UDI-DI: 10198956470347(each), 10198956470347(case), Lot Number: 5155824                       ; 47) IVS3223534, UDI-DI: 10198956470347(each), 10198956470347(case), Lot Number: 5310701                       ; 48) IVS3223535, UDI-DI: 10198956527010(each), 10198956527010(case), Lot Number: 5188103                       ; 49) IVS3223535, UDI-DI: 10198956527010(each), 10198956527010(case), Lot Number: 60622168                      ; 50) IVS322358M, UDI-DI: 10195594809362(each), 10195594809362(case), Lot Number: 4249818                       ; 51) IVS322358M, UDI-DI: 10195594809362(each), 10195594809362(case), Lot Number: 4248961                       ; 52) IVS322358M, UDI-DI: 10195594809362(each), 10195594809362(case), Lot Number: 4249818                       ; 53) IVS322358M, UDI-DI: 10195594809362(each), 10195594809362(case), Lot Number: 4249818                       ; 54) IVS322358M, UDI-DI: 10195594809362(each), 10195594809362(case), Lot Number: 4249818                       ; 55) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5124984                       ; 56) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 4249818                       ; 57) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5124984                       ; 58) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5129488                       ; 59) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5188103                       ; 60) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5188103                       ; 61) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5195818                       ; 62) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5188103                       ; 63) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5188103                       ; 64) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5129488                       ; 65) IVS322358O, UDI-DI: 10198956517073(each), 10198956517073(case), Lot Number: 6051588                       ; 66) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5248375                       ; 67) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5309623                       ; 68) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5309623                       ; 69) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5310701                       ; 70) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 6051588                       ; 71) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5150160                       ; 72) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5188102                       ; 73) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5188103                       ; 74) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5350797                       ; 75) MAT42267AL, UDI-DI: 10198956120129(each), 10198956120129(case), Lot Number: 5126398                       ; 76) MAT42267AL, UDI-DI: 10198956120129(each), 10198956120129(case), Lot Number: 5126398                       ; 77) MAT42267AL, UDI-DI: 10198956120129(each), 10198956120129(case), Lot Number: 5181074                       ; 78) MAT42267AL, UDI-DI: 10198956120129(each), 10198956120129(case), Lot Number: 5188102                       ; 79) MAT42267AL, UDI-DI: 10198956120129(each), 10198956120129(case), Lot Number: 5188102                       ; 80) MAT42267AL, UDI-DI: 5276968                       (each), 10198956120129(case), Lot Number: 10198956120129; 81) MAT4226725, UDI-DI: 5126398                       (each), 10198956181557(case), Lot Number: 10198956181557; 82) MAT422677G, UDI-DI: 10198956120136(each), 10198956120136(case), Lot Number: 5126398                       ; 83) MAT422677G, UDI-DI: 10198956120136(each), 10198956120136(case), Lot Number: 5126398                       ; 84) MAT422677G, UDI-DI: 10198956120136(each), 10198956120136(case), Lot Number: 5129058                       ; 85) MAT422677G, UDI-DI: 10198956120136(each), 10198956120136(case), Lot Number: 5126398                       ; 86) MAT422677G, UDI-DI: 10198956120136(each), 10198956120136(case), Lot Number: 5210853                       ; 87) MAT4226792, UDI-DI: 10198956207974(each), 10198956207974(case), Lot Number: 5129058                       ; 88) MAT4226793, UDI-DI: 10198956426405(each), 10198956426405(case), Lot Number: 5350797                       ; 89) MAT4226794, UDI-DI: 10198956484559(each), 10198956484559(case), Lot Number: 5309623                       ; 90) MAT4226794, UDI-DI: 10198956484559(each), 10198956484559(case), Lot Number: 5310701                       ; 91) MAT4226795, UDI-DI: 10198956538023(each), 10198956538023(case), Lot Number: 6051588","more_code_info":""},{"status":"Ongoing","city":"Waukegan","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99710","recalling_firm":"Cardinal Health 200, LLC","address_1":"3651 Birchwood Dr","address_2":"","postal_code":"60085-8337","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of FL, KY, MO, NC, OH, TX.","recall_number":"Z-3255-2026","product_description":"Presource Convenience Kits:  1) KIT, USGPIV                   , Catalog Number: PVMHIVMHD;   2) KIT, USGPIV                   , Catalog Number: PVMHIVM14;   3) KIT, USGPIV                   , Catalog Number: PVMHIVM15","product_quantity":"9480 kits","reason_for_recall":"The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or soft tissue infection. Less commonly, systemic infection or other infectious complications may occur.","recall_initiation_date":"20260810","center_classification_date":"20260922","report_date":"20260930","code_info":"1) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 20                            ; 2) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5126398                       ; 3) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5126398                       ; 4) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5129488                       ; 5) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5181074                       ; 6) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5181074                       ; 7) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5182660                       ; 8) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5188103                       ; 9) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5126398                       ; 10) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5181074                       ; 11) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5188103                       ; 12) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5188102                       ; 13) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5199118                       ; 14) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5188103                       ; 15) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5195818                       ; 16) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5150160                       ; 17) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5195818                       ; 18) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5210853                       ; 19) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5248375                       ; 20) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5276968                       ; 21) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5350797                       ; 22) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5279226                       ; 23) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5350797                       ; 24) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5307185                       ; 25) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5310701                       ; 26) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 6051588                       ; 27) PVMHIVM14, UDI-DI: 10198956165434(each), 50198956165432(case), Lot Number: 5126398                       ; 28) PVMHIVM15, UDI-DI: 10198956184459(each), 50198956184457(case), Lot Number: 5129058","more_code_info":""}]}}