← FDA ENFORCEMENT
Z-3254-2026Class II

Cardinal Health 200, LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Cardinal Health 200, LLC
Product type
Device
Status
Ongoing
Report date
2026-09-30
Distribution
US Nationwide distribution in the states of FL, KY, MO, NC, OH, TX.
Firm state
IL
Product quantity
17503 kits
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
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.

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

Code / lot 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

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Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →