Is Cardinal Health 200, LLC recalled?

Yes — a recall has been published. 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.

TemporalFDAEn curso

Puede causar daños que por lo general son pasajeros.

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

La agencia publicó este retiro solo en inglés. El nombre del producto y los códigos del paquete se muestran tal como los escribió la agencia, para que coincidan exactamente con su paquete.

Revise el dispositivo o su empaque

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

Motivo: 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.La agencia escribió este motivo solo en inglés.La agencia escribió este motivo solo en inglés.
Distribuido: US Nationwide distribution in the states of FL, KY, MO, NC, OH, TX.
Empresa: Cardinal Health 200, LLC
Anunciado: 30 de septiembre de 2026Esta es la fecha en que se anunció el retiro. La empresa pudo haberlo iniciado semanas antes.
El retiro comenzó: 10 de agosto de 2026

Fuente: registro Z-3254-2026 de FDA · consultado el 22 de septiembre de 2026

Leer el aviso oficial

Cada retiro — de alimentos, medicamentos o dispositivos médicos — se muestra palabra por palabra del aviso oficial de la FDA o del USDA, con un enlace directo. Aquí nada se resume, se reescribe ni se rellena. Este sitio no está afiliado a ninguna agencia del gobierno.