{ "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": "2026-09-24", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "222259", "product_res_number": "Z-3254-2026", "event_date_initiated": "2026-08-10", "event_date_posted": "2026-09-22", "recall_status": "Open, Classified", "res_event_number": "99710", "product_code": "LRP", "product_description": "Presource Convenience Kits:\r\n1) KIT, PRE OP , Catalog Number: AMN548616A; \r\n2) KIT, NICU ADMIT NEW HAN , Catalog Number: BA1DH0116B; \r\n3) KIT, PRE PROCEDURE , Catalog Number: IVSJV8302E; \r\n4) KIT, IV SUPPLIES , Catalog Number: IVS3223531; \r\n5) KIT, IV SUPPLIES , Catalog Number: IVS3223532; \r\n6) KIT, IV SUPPLIES , Catalog Number: IVS3223533; \r\n7) KIT, IV SUPPLIES , Catalog Number: IVS3223534; \r\n8) KIT, IV SUPPLIES , Catalog Number: IVS3223535; \r\n9) KIT, IV SUPPLIES , Catalog Number: IVS322358M; \r\n10) KIT, IV SUPPLIES , Catalog Number: IVS322358N; \r\n11) KIT, IV SUPPLIES , Catalog Number: IVS322358O; \r\n12) KIT, PATIENT ADMISSIONS , Catalog Number: AMN333032A; \r\n13) KIT, C SECTION , Catalog Number: MAT42267AL; \r\n14) KIT, C SECTION , Catalog Number: MAT4226725; \r\n15) KIT, VAGINAL DELIVERY , Catalog Number: MAT422677G; \r\n16) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226792; \r\n17) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226793; \r\n18) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226794; \r\n19) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226795", "code_info": "1) AMN548616A, UDI-DI: 10197106721834(each), 10197106721834(case), Lot Number: 4249818 ;\n2) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5124984 ;\n3) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5129488 ;\n4) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5129488 ;\n5) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5188103 ;\n6) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5188103 ;\n7) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5211212 ;\n8) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5155824 ;\n9) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5211985 ;\n10) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5279226 ;\n11) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5155824 ;\n12) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5188103 ;\n13) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5211212 ;\n14) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5246952 ;\n15) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5279226 ;\n16) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5279226 ;\n17) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 6062168 ;\n18) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5155824 ;\n19) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5279226 ;\n20) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 6062168 ;\n21) BA1DH0116B, UDI-DI: 0(each), 0(case), Lot Number: 6051588 ;\n22) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5124984 ;\n23) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5124984 ;\n24) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488 ;\n25) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5124984 ;\n26) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488 ;\n27) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488 ;\n28) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5188103 ;\n29) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5195818 ;\n30) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211907 ;\n31) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211985 ;\n32) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211212 ;\n33) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211985 ;\n34) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5279226 ;\n35) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488 ;\n36) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211985 ;\n37) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 6037918 ;\n38) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488 ;\n39) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5155824 ;\n40) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5279226 ;\n41) IVS3223531, UDI-DI: 10198956173941(each), 10198956173941(case), Lot Number: 5124984 ;\n42) IVS3223532, UDI-DI: 10198956173958(each), 10198956173958(case), Lot Number: 5124984 ;\n43) IVS3223533, UDI-DI: 10198956362536(each), 10198956362536(case), Lot Number: 5188103 ;\n44) IVS3223533, UDI-DI: 10198956362536(each), 10198956362536(case), Lot Number: 5211985 ;\n45) IVS3223534, UDI-DI: 10198956470347(each), 10198956470347(case), Lot Number: 5129488 ;\n46) IVS3223534, UDI-DI: 10198956470347(each), 10198956470347(case), Lot Number: 5155824 ;\n47) IVS3223534, UDI-DI: 10198956470347(each), 10198956470347(case), Lot Number: 5310701 ;\n48) IVS3223535, UDI-DI: 10198956527010(each), 10198956527010(case), Lot Number: 5188103 ;\n49) IVS3223535, UDI-DI: 10198956527010(each), 10198956527010(case), Lot Number: 60622168 ;\n50) IVS322358M, UDI-DI: 10195594809362(each), 10195594809362(case), Lot Number: 4249818 ;\n51) IVS322358M, UDI-DI: 10195594809362(each), 10195594809362(case), Lot Number: 4248961 ;\n52) IVS322358M, UDI-DI: 10195594809362(each), 10195594809362(case), Lot Number: 4249818 ;\n53) IVS322358M, UDI-DI: 10195594809362(each), 10195594809362(case), Lot Number: 4249818 ;\n54) IVS322358M, UDI-DI: 10195594809362(each), 10195594809362(case), Lot Number: 4249818 ;\n55) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5124984 ;\n56) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 4249818 ;\n57) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5124984 ;\n58) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5129488 ;\n59) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5188103 ;\n60) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5188103 ;\n61) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5195818 ;\n62) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5188103 ;\n63) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5188103 ;\n64) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5129488 ;\n65) IVS322358O, UDI-DI: 10198956517073(each), 10198956517073(case), Lot Number: 6051588 ;\n66) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5248375 ;\n67) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5309623 ;\n68) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5309623 ;\n69) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5310701 ;\n70) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 6051588 ;\n71) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5150160 ;\n72) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5188102 ;\n73) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5188103 ;\n74) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5350797 ;\n75) MAT42267AL, UDI-DI: 10198956120129(each), 10198956120129(case), Lot Number: 5126398 ;\n76) MAT42267AL, UDI-DI: 10198956120129(each), 10198956120129(case), Lot Number: 5126398 ;\n77) MAT42267AL, UDI-DI: 10198956120129(each), 10198956120129(case), Lot Number: 5181074 ;\n78) MAT42267AL, UDI-DI: 10198956120129(each), 10198956120129(case), Lot Number: 5188102 ;\n79) MAT42267AL, UDI-DI: 10198956120129(each), 10198956120129(case), Lot Number: 5188102 ;\n80) MAT42267AL, UDI-DI: 5276968 (each), 10198956120129(case), Lot Number: 10198956120129;\n81) MAT4226725, UDI-DI: 5126398 (each), 10198956181557(case), Lot Number: 10198956181557;\n82) MAT422677G, UDI-DI: 10198956120136(each), 10198956120136(case), Lot Number: 5126398 ;\n83) MAT422677G, UDI-DI: 10198956120136(each), 10198956120136(case), Lot Number: 5126398 ;\n84) MAT422677G, UDI-DI: 10198956120136(each), 10198956120136(case), Lot Number: 5129058 ;\n85) MAT422677G, UDI-DI: 10198956120136(each), 10198956120136(case), Lot Number: 5126398 ;\n86) MAT422677G, UDI-DI: 10198956120136(each), 10198956120136(case), Lot Number: 5210853 ;\n87) MAT4226792, UDI-DI: 10198956207974(each), 10198956207974(case), Lot Number: 5129058 ;\n88) MAT4226793, UDI-DI: 10198956426405(each), 10198956426405(case), Lot Number: 5350797 ;\n89) MAT4226794, UDI-DI: 10198956484559(each), 10198956484559(case), Lot Number: 5309623 ;\n90) MAT4226794, UDI-DI: 10198956484559(each), 10198956484559(case), Lot Number: 5310701 ;\n91) MAT4226795, UDI-DI: 10198956538023(each), 10198956538023(case), Lot Number: 6051588", "firm_fei_number": "3001236905", "recalling_firm": "Cardinal Health 200, LLC", "address_1": "3651 Birchwood Dr", "city": "Waukegan", "state": "IL", "postal_code": "60085-8337", "additional_info_contact": "Cardinal Health Quality Systems\n800-292-9332", "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.", "root_cause_description": "Nonconforming Material/Component", "action": "An URGENT: PRODUCT CORRECTION notification letter dated 8/10/26 was sent to customers.\n\nIf you locate affected product within your facility, please do the following:\n1. QUARANTINE affected kits.\n2. ALERT your clinicians of this action.\n3. AFFIX a WARNING LABEL to the front of each Presource kit so that it is clearly visible to\nclinicians, instructing them to remove and discard the recalled component(s).\n4. RETURN a copy of the enclosed Acknowledgment Form confirming your receipt of this\naction and the completion of labeling product via fax to 614.652.9648.\nAdditional labels will be sent to your facility upon request. Please send an email to:\ngmb-FieldCorrectiveAction@cardinalhealth.com\nFor component credit or replacement, please contact the following:\n\" Hospitals Cardinal Customer Service at 866.551.0533\n\" Distributors Distributor Management at 800.635.6021\n\" Federal Government facilities Government Customer Service at 800.444.1166\nIf you are a Distributor and have further distributed affected kits please notify your customers of this recall.\nShould you have any questions, require additional labels or desire special assistance relating to this recall, please feel free to contact Cardinal Health Quality Systems at 800.292.9332.", "product_quantity": "17503 kits", "distribution_pattern": "US Nationwide distribution in the states of FL, KY, MO, NC, OH, TX.", "openfda": { "k_number": [ "K890071", "K861142", "K935621", "K922126", "K903544", "K940239", "K873439", "K963723", "K760497", "K873290", "K903963", "K883098", "K940646", "K882275", "K905462", "K951811", "K873469", "K903962", "K881095", "K912105", "K940444", "K874665" ], "registration_number": [ "1720747", "1054241", "1823410", "3010009693", "3004215117", "3007494564", "3009554293", "3015351976", "3010376936", "1820334", "9680168", "3008338766", "8030607", "3007589150", "1649390", "1928237", "1047429", "3045058049", "3006554788", "2242056", "3005809810", "9710629", "8040278", "3010667733", "3008812560", "3010097171", "1836161", "9710524", "3002862271", "3011301313", "3015168527", "3008902714", "1048735", "3007420745", "9611503", "3005182241", "3005108347", "8010099", "1417592", "9680909", "3010757045", "1055236", "9681622", "1650372", "3025663209", "1043214", "1721686", "3011196443", "3015276780", "3032747418", "1222780", "3003877407", "1643817", "2084725", "3010453282", "3009538923", "3009255580", "1833824", "3013602181", "2320762", "2027062", "9615270", "3009702671", "3009158523", "1834379", "9680357", "3009513193", "3008392711", "9680411", "1412854", "1646747", "9611610", "3003120897", "3003322138", "1450662", "3004608878", "3045857302", "3002669946", "8010177", "3007773213", "1057404", "3010039499", "3015876273", "1123137", "1835444", "1527736", "1423537", "1043572", "3011767135", "3006128100", "1422507", "3018167761", "1037577", "3009465247", "3011749806", "9613079", "1935627", "9617297", "1060680", "1929756", "1824619", "3010622588", "3008559312", "3038632739", "3004521401", "2529846", "3010303097", "9611062", "8040233", "3038613790", "2242656", "3008323540", "3011371465", "8043816", "3002808270", "1923569", "3008513424", "3002675176", "9612420", "2433012", "3007539489", "3007485169", "3027305775", "3005245797", "3034676720", "1030489", "8010944", "3009584307", "3026326493", "8030673", "3012104006", "3016659819", "3008770252", "3006210673", "3013947859", "3004122598", "1000124971", "8040881", "3011137372", "3003032798", "3042989733", "3008346537", "3008936260", "3025107383", "1314417", "1825034", "3010598169", "9681599", "3009420946", "1061124", "9611367", "3025905693", "9680244", "3005641619", "3006272282", "9613926", "1121091", "3009888344", "3000199132", "9616088", "3004788213", "1066741", "3009887475", "3006215390", "3010041511", "3012447612", "3031284747", "1834331", "3017410889", "3005031160", "1420054", "3011577940", "3009140376", "2183785", "3013247477", "3012421607", "3043164947", "9610612", "3005440795", "3008534770", "3035858921", "1221053", "2126376", "3012251300", "8010890", "5906", "3042624965", "3005625540", "3014967149", "3006636962", "8031020", "2029015", "3010864832", "3024988980", "3013503739", "3016050940", "3044150131", "3017896194", "3005075853", "3003418325", "3013846070", "1032347", "1045834", "3005071827", "3009340886", "3003431869", "1225691", "3012429289", "3003761012", "3022320321", "3014644369", "3009010435", "3010726901", "1043534", "1018470", "3015173212", "3002821232", "3003924117", "3005467144", "3013358456", "2084346", "2424366", "3008773560", "9610773", "3004519921", "2249529", "1123010", "3014314985", "3021023132", "3008489813", "3000270450", "3035678069", "3027320022", "3002834291", "3009165919", "3001650535", "1030451", "3010235355", "3005360851", "3014257280", "3003759558", "3016171961", "3019455", "3004111573", "3008747271", "3001084743", "3006191977", "3022378059", "3012944064", "3013497507", "3018094310", "3009540749", "3036002406", "1056350", "3009110133", "1832228", "3010399422", "3031582434", "3016170492", "1421879", "3026057410", "3005528784", "3009417901", "2000028362", "3013011598", "2184066", "3007329020", "3024706750", "3027847726", "3035642068", "3015991317", "3004082002", "3014908171", "3005669815", "3010583458", "3011526299", "3010829427", "3010452421", "1648571", "3031240334", "1223662", "1422634", "9611579", "3009756153", "3007137643", "3004941127", "3005595283" ], "fei_number": [ "1720747", "3002807156", "1823410", "3010009693", "3004215117", "3007494564", "3009554293", "3015351976", "3010376936", "1820334", "3003499455", "3008338766", "3007589150", "3002807798", "1000160458", "1928237", "1047429", "3045058049", "3006554788", "2242056", "3005809810", "3003662624", "1000140363", "3010667733", "3008812560", "1000123180", "3010097171", "3005985723", "3005734757", "3004216008", "3002862271", "3011301313", "3015168527", "3008902714", "1048735", "3007420745", "3005182241", "1417592", "3010757045", "3025663209", "3008205331", "1721686", "3011196443", "3015276780", "3000205950", "3032747418", "1043214", "3002807183", "1000477302", "3003877407", "1643817", "3010453282", "3009538923", "3009255580", "3013602181", "1000208576", "3009702671", "3009158523", "2027062", "3009513193", "3008392711", "1412854", "3003120897", "3003322138", "1450662", "3004608878", "3045857302", "3002669946", "3007773213", "3002750084", "3010039499", "3015876273", "1527736", "1043572", "3011767135", "3002786339", "3006128100", "3002750002", "3018167761", "1037577", "3009465247", "1000484507", "3011749806", "1935627", "1929756", "1824619", "3010622588", "3008559312", "3038632739", "3004521401", "3010303097", "3004829691", "3038613790", "2242656", "3008323540", "3011371465", "3002902735", "3002253367", "5870", "1000208624", "3002808270", "3002904345", "3008513424", "1923569", "3002675176", "3003040625", "1000159368", "2433012", "3007539489", "3007485169", "3027305775", "3005245797", "3034676720", "1000514656", "3003200961", "3009584307", "3026326493", "3002807214", "3012104006", "3016659819", "3008770252", "3006210673", "3013947859", "3004122598", "1000124971", "3002806545", "3004150667", "3003032798", "3002807264", "3005846326", "3004213967", "3042989733", "3008346537", "3008936260", "3025107383", "1314417", "1825034", "3010598169", "3009420946", "1000508235", "3005641619", "3025905693", "1000115331", "3006272282", "1121091", "3009888344", "3000199132", "3004788213", "3001451466", "3009887475", "3006215390", "3010041511", "3012447612", "3031284747", "3005031160", "1420054", "3011577940", "3009140376", "1000112968", "3013247477", "3012421607", "3043164947", "2183785", "3005440795", "3008534770", "3035858921", "1221053", "2126376", "3012251300", "1000115761", "5906", "3042624965", "3005625540", "3014967149", "3006636962", "3002821504", "3002807830", "1000402972", "3044150131", "3024988980", "3013503739", "3016050940", "3003005156", "3017896194", "3005075853", "3003418325", "3013846070", "3003407235", "3001236905", "1000124817", "1032347", "1045834", "3005071827", "3009340886", "3003431869", "3012429289", "3003761012", "3022320321", "1000112877", "3014644369", "3000718467", "3009010435", "3010726901", "1043534", "1018470", "3015173212", "3002821232", "3003924117", "3005467144", "3013358456", "1000160162", "2424366", "3008773560", "3002808335", "3000717687", "3014314985", "3010862763", "3021023132", "3008489813", "3000270450", "3035678069", "3027320022", "3002834291", "3007264034", "3009165919", "3001650535", "3003944071", "3006509795", "1030451", "3010235355", "3005360851", "3002648735", "3014257280", "1000115048", "3003759558", "3016171961", "3019455", "3004111573", "3008747271", "3001084743", "3006191977", "3022378059", "3012944064", "3013497507", "3018094310", "3009540749", "3036002406", "1000306340", "3009110133", "1832228", "3010399422", "3031582434", "1000123297", "3016170492", "3026057410", "3005528784", "3009417901", "2000028362", "3013011598", "3002807169", "3002806315", "1000136191", "3007329020", "3024706750", "1000512168", "3027847726", "3035642068", "3015991317", "3004082002", "3014908171", "3005669815", "3010583458", "3011526299", "3010829427", "3010452421", "3031240334", "1000295034", "3429", "1000159990", "1000120743", "3009756153", "3005747797", "3007137643", "1000306303", "3004941127", "3005595283" ], "device_name": "Tray, Surgical", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4800", "device_class": "1" } } ] }