medical MODERATE Updated 2026-09-30

Cardinal Health 200, LLC recalls Presource Convenience Kits: 1) KIT, PRE OP

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Recalled Product

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

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Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/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

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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