RecallHawk
Class II Recall

Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, C

Cardinal Health 200, LLC

Summary

The FDA issued a Class II for Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHI by Cardinal Health 200, LLC. Reason: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits..

Details

Source

Device Recall

External ID

Z-1134-2025

Action Date

2025-02-19

Status

Ongoing

Category

device

Product Description

Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC13 3) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC14 4) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC15 5) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC16 6) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC17 7) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC18 8) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC1D 9) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC22 10) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC23 11) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC24 12) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC25 13) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC26 14) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC2C 15) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP32 16) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP33 17) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP34 18) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP3D 19) KIT, VP SHUNT, Catalog Number:P55VNVP09A 20) KIT,ANT CERVICAL DISK,MO BAP, Catalog Number:PGVMACMOQ 21) KIT, CRANIOTOMY, Catalog Number:PN11CNC10 22) KIT, CRANIOTOMY, Catalog Number:PN11CNC11 23) KIT, CRANIOTOMY, Catalog Number:PN11CNC12 24) KIT, CRANIOTOMY, Catalog Number:PN11CNC13 25) KIT, CRANIOTOMY, Catalog Number:PN11CNC14 26) KIT, CRANIOTOMY, Catalog Number:PN11CNC15 27) KIT, CRANIOTOMY, Catalog Number:PN11CNC16 28) KIT, CRANIOTOMY, Catalog Number:PN11CNC17 29) KIT, CRANIOTOMY, Catalog Number:PN11CNC18 30) KIT, CRANIOTOMY, Catalog Number:PN11CNC19 31) KIT, CRANIOTOMY, Catalog Number:PN11CNC20 32) KIT, CRANIOTOMY, Catalog Number:PN11CNCH7 33) KIT, CRANIOTOMY, Catalog Number:PN11CNCH8 34) KIT, CRANIOTOMY, Catalog Number:PN11CNCH9 35) KIT, CRANIOTOMY, Catalog Number:PN11CNCHN 36) KIT, CRANIOTOMY, Catalog Number:PN11CNCHO 37) KIT, CRANIOTOMY, Catalog Number:PN11CNCHQ 38) KIT, CRANIOTOMY, Catalog Number:PN11CNCHR 39) KIT, CRANIOTOMY, Catalog Number:PN11CNCHS 40) KIT, CRANIOTOMY, Catalog Number:PN11CNCHT 41) KIT, CRANIOTOMY, Catalog Number:PN11CNCHU 42) KIT, CRANIOTOMY, Catalog Number:PN11CNCHV 43) KIT, NEURO SJMC, Catalog Number:PN11NEXX2 44) KIT, NEURO SJMC, Catalog Number:PN11NEXX3 45) KIT, NEURO SJMC, Catalog Number:PN11NEXX4 46) KIT, NEURO SJMC, Catalog Number:PN11NEXX5 47) KIT, NEURO SJMC, Catalog Number:PN11NEXX6 48) KIT, NEURO SJMC, Catalog Number:PN11NEXX7 49) KIT, NEURO SJMC, Catalog Number:PN11NEXXB 50) KIT, NEURO SJMC, Catalog Number:PN11NEXXD 51) KIT, NEURO SJMC, Catalog Number:PN11NEXXE 52) KIT, NEURO, Catalog Number:PN11OTR10 53) KIT, NEURO, Catalog Number:PN11OTR11 54) KIT, NEURO, Catalog Number:PN11OTR12 55) KIT, NEURO, Catalog Number:PN11OTR13 56) KIT, NEURO, Catalog Number:PN11OTR14 57) KIT, NEURO, Catalog Number:PN11OTRM1 58) KIT, NEURO, Catalog Number:PN11OTRM2 59) KIT, NEURO, Catalog Number:PN11OTRM3 60) KIT, NEURO, Catalog Number:PN11OTRM4 61) KIT, NEURO, Catalog Number:PN11OTRM5 62) KIT, NEURO, Catalog Number:PN11OTRM7 63) KIT, NEURO, Catalog Number:PN11OTRM8 64) KIT, NEURO, Catalog Number:PN11OTRM9 65) NEURO, KIT, Catalog Number:PN11OTRMQ 66) KIT, NEURO, Catalog Number:PN11OTRMR 67) KIT, NEURO, Catalog Number:PN11OTRMS 68) KIT, NEURO, Catalog Number:PN11OTRMV 69) KIT, NEURO, Catalog Number:PN11OTRMW 70) KIT, SPINAL FUSION, Catalog Number:PN11SHCH5 71) KIT, SPINAL FUSION, Catalog Number:PN11SHCH6 72) KIT, SPINAL FUSION, Catalog Number:PN11SHCH7 73) KIT, SPINAL FUSION, Catalog Number:PN11SHCHQ 74) KIT, SPINAL FUSION, Catalog Number:PN11SHCHR 75) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR10 76) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR11 77) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR12 78) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR13 79) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR14 80) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR15 81) KIT, LARGE SPINE 143487, Catalog Number:PN15LSRM1 82) KIT, LARGE SPINE 143487, Catalog Number:PN15LSRM2 83) KIT, LARGE SP

Lot/Code Info: 1) CHIP99NC12, UDI-DI:10195594105471 (each) 50195594105479 (case), Lot Number: J8692J ; 2) CHIP99NC13, UDI-DI:10195594202378 (each) 50195594202376 (case), Lot Number: 5138245 ; 3) CHIP99NC14, UDI-DI:10195594276898 (each) 50195594276896 (case), Lot Number: 5324036 ; 4) CHIP99NC15, UDI-DI:10195594399696 (each) 50195594399694 (case), Lot Number: 5530905 ; 5) CHIP99NC16, UDI-DI:10195594444846 (each) 50195594444844 (case), Lot Number: 5530911 ; 6) CHIP99NC17, UDI-DI:10197106046159 (each) 50197106046157 (case), Lot Number: 6560930 ; 7) CHIP99NC18, UDI-DI:10197106169643 (each) 50197106169641 (case), Lot Number: 6701892 ; 8) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 6264447 ; 9) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 6986972 ; 10) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 7005424 ; 11) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J4218Z ; 12) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J4678H ; 13) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J4678T ; 14) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J4950P ; 15) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J53W06 ; 16) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: N/A ; 17) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J6049N ; 18) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J6365Y ; 19) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J77Z27 ; 20) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J82M02 ; 21) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: N/A ; 22) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J8393C ; 23) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J84J89 ; 24) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: N/A ; 25) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J6910P ; 26) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J9602N ; 27) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 5664019 ; 28) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 5664026 ; 29) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 5891284 ; 30) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 5631036 ; 31) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 6022056 ; 32) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 6264450 ; 33) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 6345501 ; 34) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 6563903 ; 35) CHIP99NC22, UDI-DI:10195594192273 (each) 50195594192271 (case), Lot Number: 1055391 ; 36) CHIP99NC22, UDI-DI:10195594192273 (each) 50195594192271 (case), Lot Number: 5138240 ; 37) CHIP99NC23, UDI-DI:10195594229412 (each) 50195594229410 (case), Lot Number: 5311235 ; 38) CHIP99NC24, UDI-DI:10195594374297 (each) 50195594374295 (case), Lot Number: 5138222 ; 39) CHIP99NC25, UDI-DI:10195594416966 (each) 50195594416964 (case), Lot Number: 5530901 ; 40) CHIP99NC26, UDI-DI:10195594484736 (each) 50195594484734 (case), Lot Number: 5631034 ; 41) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7332815 ; 42) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7280043 ; 43) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 6264447 ; 44) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 6905474 ; 45) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7058621 ; 46) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7005446 ; 47) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 6701940 ; 48) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7055834 ; 49) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7260062 ; 50) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7260064 ; 51) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7280036 ; 52) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7280061 ; 53) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7160480 ; 54) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7260073 ; 55) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7331292 ; 56) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7331290 ; 57) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J4678H ; 58) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J4679N ; 59) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J4678W ; 60) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: N/A ; 61) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J5678T ; 62) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J53W12 ; 63) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J6049N ; 64) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J6049Y ; 65) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J77Z26 ; 66) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J7904P ; 67) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J82M03 ; 68) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J8491U ; 69) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J84J86 ; 70) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: N/A ; 71) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J6365Z ; 72) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J96N39 ; 73) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J6365K ; 74) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 5699520 ; 75) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 5699520 ; 76) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 5891286 ; 77) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 6485583 ; 78) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 6563907 ; 79) CHIP99SP32, UDI-DI:10195594140274 (each) 50195594140272 (case), Lot Number: 5138228 ; 80) CHIP99SP33, UDI-DI:10195594229733 (each) 50195594229731 (case), Lot Number: 5311233 ; 81) CHIP99SP34, UDI-DI:10195594303280 (each) 50195594303288 (case), Lot Number: 5372220 ; 82) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 6022059 ; 83) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 6905475 ; 84) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7005449 ; 85) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7055834 ; 86) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7122100 ; 87) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7260057 ; 88) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7260066 ; 89) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7260068 ; 90) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7260070 ; 91) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7280037 ; 92) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7260072 ; 93) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7287459 ; 94) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7287469 ; 95) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 6485591 ; 96) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7332810 ; 97) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J3986J ; 98) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J4678M ; 99) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7332837 ; 100) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J4679H ; 101) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J4950G ; 102) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7360138 ; 103) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J4950U ; 104) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J4951G ; 105) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: N/A ; 106) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J5678T ; 107) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J8670H ; 108) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J6785Z ; 109) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J93M83 ; 110) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 5405614 ; 111) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 5631031 ; 112) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 5664020 ; 113) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 5699520 ; 114) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 6022054 ; 115) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 6345500 ; 116) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 6563903 ; 117) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 6563910 ; 118) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 6701967 ; 119) P55VNVP09A, UDI-DI:10888439614749 (each) 50888439614747 (case), Lot Number: J4680A ; 120) P55VNVP09A, UDI-DI:10888439614749 (each) 50888439614747 (case), Lot Number: J6049T ; 121) P55VNVP09A, UDI-DI:10888439614749 (each) 50888439614747 (case), Lot Number: J6277P ; 122) P55VNVP09A, UDI-DI:10888439614749 (each) 50888439614747 (case), Lot Number: J76N01 ; 123) P55VNVP09A, UDI-DI:10888439614749 (each) 50888439614747 (case), Lot Number: J7904R ; 124) PGVMACMOQ, UDI-DI:10887488851532 (each) 50887488851530 (case), Lot Number: J3986G ; 125) PGVMACMOQ, UDI-DI:10887488851532 (each) 50887488851530 (case), Lot Number: J4678Z ; 126) PGVMACMOQ, UDI-DI:10887488851532 (each) 50887488851530 (case), Lot Number: J4679C ; 127) PGVMACMOQ, UDI-DI:10887488851532 (each) 50887488851530 (case), Lot Number: J4679G ; 128) PGVMACMOQ, UDI-DI:10887488851532 (each) 50887488851530 (case), Lot Number: J4680C ; 129) PN11CNC10, UDI-DI:10195594392536 (each) 50195594392534 (case), Lot Number: 5405610 ; 130) PN11CNC11, UDI-DI:10195594511968 (each) 50195594511966 (case), Lot Number: 5508042 ; 131) PN11CNC12, UDI-DI:10195594565459 (each) 50195594565457 (case), Lot Number: J6049X ; 132) PN11CNC13, UDI-DI:10195594610982 (each) 50195594610980 (case), Lot Number: 5891282 ; 133) PN11CNC14, UDI-DI:10195594774462 (each) 50195594774460 (case), Lot Number: 6022061 ; 134) PN11CNC15, UDI-DI:10195594808952 (each) 50195594808950 (case), Lot Number: 6411398 ; 135) PN11CNC16, UDI-DI:10197106329207 (each) 50197106329205 (case), Lot Number: 7005438 ; 136) PN11CNC17, UDI-DI:10197106448922 (each) 50197106448920 (case), Lot Number: 7122100 ; 137) PN11CNC18, UDI-DI:10197106529485 (each) 50197106529483 (case), Lot Number: 7280036 ; 138) PN11CNC19, UDI-DI:10197106646151 (each) 50197106646159 (case), Lot Number: 7331285 ; 139) PN11CNC20, UDI-DI:10197106800867 (each) 50197106800865 (case), Lot Number: 7365538 ; 140) PN11CNCH7, UDI-DI:10195594061531 (each) 50195594061539 (case), Lot Number: 5136008 ; 141) PN11CNCH8, UDI-DI:10195594126414 (each) 50195594126412 (case), Lot Number: 5136036 ; 142) PN11CNCH9, UDI-DI:10195594246341 (each) 50195594246349 (case), Lot Number: 5138246 ; 143) PN11CNCHN, UDI-DI:10888439472288 (each) 50888439472286 (case), Lot Number: J3986G ; 144) PN11CNCHO, UDI-DI:10888439575491 (each) 50888439575499 (case), Lot Number: J4678K ; 145) PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case), Lot Number: J4949Z ; 146) PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case), Lot Number: J4951A ; 147) PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case), Lot Number: J53W18 ; 148) PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case), Lot Number: J6365X ; 149) PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case), Lot Number: J76N04 ; 150) PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case), Lot Number: J82M03 ; 151) PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case), Lot Number: J6365U ; 152) PN11CNCHR, UDI-DI:10195594910211 (each) 50195594910219 (case), Lot Number: J6910U ; 153) PN11CNCHR, UDI-DI:10195594910211 (each) 50195594910219 (case), Lot Number: J96A00 ; 154) PN11CNCHR, UDI-DI:10195594910211 (each) 50195594910219 (case), Lot Number: 5530913 ; 155) PN11CNCHR, UDI-DI:10195594910211 (each) 50195594910219 (case), Lot Number: 5631029 ; 156) PN11CNCHS, UDI-DI:10195594494582 (each) 50195594494580 (case), Lot Number: 5891291 ; 157) PN11CNCHT, UDI-DI:10195594760090 (each) 50195594760098 (case), Lot Number: 6907768 ; 158) PN11CNCHT, UDI-DI:10195594760090 (each) 50195594760098 (case), Lot Number: 6485580 ; 159) PN11CNCHT, UDI-DI:10195594760090 (each) 50195594760098 (case), Lot Number: 6687084 ; 160) PN11CNCHT, UDI-DI:10195594760090 (each) 50195594760098 (case), Lot Number: 6687083 ; 161) PN11CNCHU, UDI-DI:10197106307496 (each) 50197106307494 (case), Lot Number: 7260062 ; 162) PN11CNCHV, UDI-DI:10197106550212 (each) 50197106550210 (case), Lot Number: 7287465 ; 163) PN11CNCHV, UDI-DI:10197106550212 (each) 50197106550210 (case), Lot Number: 7331284 ; 164) PN11CNCHV, UDI-DI:10197106550212 (each) 50197106550210 (case), Lot Number: 7331283 ; 165) PN11CNCHV, UDI-DI:10197106550212 (each) 50197106550210 (case), Lot Number: 7331456 ; 166) PN11CNCHV, UDI-DI:10197106550212 (each) 50197106550210 (case), Lot Number: 7332825 ; 167) PN11NEXX2, UDI-DI:10195594290368 (each) 50195594290366 (case), Lot Number: 5324047 ; 168) PN11NEXX3, UDI-DI:10195594586072 (each) 50195594586070 (case), Lot Number: 5664035 ; 169) PN11NEXX4, UDI-DI:10197106006191 (each) 50197106006199 (case), Lot Number: 6485583 ; 170) PN11NEXX5, UDI-DI:10197106589069 (each) 50197106589067 (case), Lot Number: 7287456 ; 171) PN11NEXX6, UDI-DI:10197106714799 (each) 50197106714797 (case), Lot Number: 7332807 ; 172) PN11NEXX7, UDI-DI:10197106725498 (each) 50197106725496 (case), Lot Number: 7332815 ; 173) PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case), Lot Number: J6049W ; 174) PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case), Lot Number: J6277M ; 175) PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case), Lot Number: J76N03 ; 176) PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case), Lot Number: J7962U ; 177) PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case), Lot Number: J8392Z ; 178) PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case), Lot Number: J90H78 ; 179) PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case), Lot Number: J6786G ; 180) PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case), Lot Number: J70X16 ; 181) PN11NEXXD, UDI-DI:10195594975043 (each) 50195594975041 (case), Lot Number: 5135980 ; 182) PN11NEXXD, UDI-DI:10195594975043 (each) 50195594975041 (case), Lot Number: 5138245 ; 183) PN11NEXXD, UDI-DI:10195594975043 (each) 50195594975041 (case), Lot Number: 5 ; 184) PN11NEXXD, UDI-DI:10195594975043 (each) 50195594975041 (case), Lot Number: 5530889 ; 185) PN11NEXXD, UDI-DI:10195594975043 (each) 50195594975041 (case), Lot Number: 5631031 ; 186) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 6907761 ; 187) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 7058621 ; 188) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 7122004 ; 189) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 6907748 ; 190) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 7055836 ; 191) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 7160474 ; 192) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 7260069 ; 193) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 7287472 ; 194) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 6560923 ; 195) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: J6365M ; 196) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 5891296 ; 197) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 6022052 ; 198) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 6264450 ; 199) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 6687061 ; 200) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 6687082 ; 201) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 6701945 ; 202) PN11OTR10, UDI-DI:10197106121214 (each) 50197106121212 (case), Lot Number: 6560956 ; 203) PN11OTR11, UDI-DI:10197106238080 (each) 50197106238088 (case), Lot Number: 6702040 ; 204) PN11OTR12, UDI-DI:10197106342343 (each) 50197106342341 (case), Lot Number: 6702040 ; 205) PN11OTR13, UDI-DI:10197106419526 (each) 50197106419524 (case), Lot Number: 6806122 ; 206) PN11OTR14, UDI-DI:10197106560525 (each) 50197106560523 (case), Lot Number: 7287574 ; 207) PN11OTRM1, UDI-DI:10195594004057 (each) 50195594004055 (case), Lot Number: J8998R ; 208) PN11OTRM2, UDI-DI:10195594177089 (each) 50195594177087 (case), Lot Number: 5140388 ; 209) PN11OTRM3, UDI-DI:10195594276294 (each) 50195594276292 (case), Lot Number: 5140390 ; 210) PN11OTRM4, UDI-DI:10195594412296 (each) 50195594412294 (case), Lot Number: 5533344 ; 211) PN11OTRM5, UDI-DI:10195594494964 (each) 50195594494962 (case), Lot Number: J65K19 ; 212) PN11OTRM7, UDI-DI:10195594687755 (each) 50195594687753 (case), Lot Number: 5918342 ; 213) PN11OTRM8, UDI-DI:10195594758905 (each) 50195594758903 (case), Lot Number: 6251073 ; 214) PN11OTRM9, UDI-DI:10197106055694 (each) 50197106055692 (case), Lot Number: 6345528 ; 215) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J3593P ; 216) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J4220C ; 217) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J43W15 ; 218) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J46C10 ; 219) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J4953C ; 220) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J4953F ; 221) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J6022K ; 222) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J6022K ; 223) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J6373A ; 224) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J7708T ; 225) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J79Z50 ; 226) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J4953F ; 227) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J79Z51 ; 228) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J87C82 ; 229) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J8998R ; 230) PN11OTRMR, UDI-DI:10195594238391 (each) 50195594238399 (case), Lot Number: 5858469 ; 231) PN11OTRMS, UDI-DI:10195594713362 (each) 50195594713360 (case), Lot Number: 6251078 ; 232) PN11OTRMS, UDI-DI:10195594713362 (each) 50195594713360 (case), Lot Number: 6251076 ; 233) PN11OTRMS, UDI-DI:10195594713362 (each) 50195594713360 (case), Lot Number: 6345528 ; 234) PN11OTRMS, UDI-DI:10195594713362 (each) 50195594713360 (case), Lot Number: 6560956 ; 235) PN11OTRMV, UDI-DI:10197106337677 (each) 50197106337675 (case), Lot Number: 7160540 ; 236) PN11OTRMV, UDI-DI:10197106337677 (each) 50197106337675 (case), Lot Number: 7160540 ; 237) PN11OTRMV, UDI-DI:10197106337677 (each) 50197106337675 (case), Lot Number: 7287574 ; 238) PN11OTRMV, UDI-DI:10197106337677 (each) 50197106337675 (case), Lot Number: 7163125 ; 239) PN11OTRMV, UDI-DI:10197106337677 (each) 50197106337675 (case), Lot Number: 7287580 ; 240) PN11OTRMV, UDI-DI:10197106337677 (each) 50197106337675 (case), Lot Number: 7331480 ; 241) PN11OTRMW, UDI-DI:10197106653715 (each) 50197106653713 (case), Lot Number: 7333447 ; 242) PN11SHCH5, UDI-DI:10888439651652 (each) 50888439651650 (case), Lot Number: J4680D ; 243) PN11SHCH5, UDI-DI:10888439651652 (each) 50888439651650 (case), Lot Number: J4950P ; 244) PN11SHCH6, UDI-DI:10888439799217 (each) 50888439799215 (case), Lot Number: J6277R ; 245) PN11SHCH7, UDI-DI:10888439845044 (each) 50888439845042 (case), Lot Number: J74A18 ; 246) PN11SHCHQ, UDI-DI:10888439472011 (each) 50888439472019 (case), Lot Number: J4219A ; 247) PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case), Lot Number: J4679X ; 248) PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case), Lot Number: J4679Z ; 249) PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case), Lot Number: J4680H ; 250) PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case), Lot Number: J4950H ; 251) PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case), Lot Number: J74A18 ; 252) PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case), Lot Number: J82K97 ; 253) PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case), Lot Number: J8123N ; 254) PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case), Lot Number: J82K96 ; 255) PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case), Lot Number: J6365U ; 256) PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case), Lot Number: J6910U ; 257) PN15LSR10, UDI-DI:10197106120965 (each) 50197106120963 (case), Lot Number: 6701948 ; 258) PN15LSR10, UDI-DI:10197106120965 (each) 50197106120963 (case), Lot Number: 6470296 ; 259) PN15LSR10, UDI-DI:10197106120965 (each) 50197106120963 (case), Lot Number: 6560949 ; 260) PN15LSR11, UDI-DI:10197106274262 (each) 50197106274260 (case), Lot Number: 6907770 ; 261) PN15LSR11, UDI-DI:10197106274262 (each) 50197106274260 (case), Lot Number: 6748354 ; 262) PN15LSR11, UDI-DI:10197106274262 (each) 50197106274260 (case), Lot Number: 6788668 ; 263) PN15LSR12, UDI-DI:10197106668764 (each) 50197106668762 (case), Lot Number: 7280050 ; 264) PN15LSR12, UDI-DI:10197106668764 (each) 50197106668762 (case), Lot Number: 7332858 ; 265) PN15LSR12, UDI-DI:10197106668764 (each) 50197106668762 (case), Lot Number: 7269982 ; 266) PN15LSR13, UDI-DI:10197106685075 (each) 50197106685073 (case), Lot Number: 6560923 ; 267) PN15LSR13, UDI-DI:10197106685075 (each) 50197106685073 (case), Lot Number: 7331313 ; 268) PN15LSR13, UDI-DI:10197106685075 (each) 50197106685073 (case), Lot Number: 7365541 ; 269) PN15LSR14, UDI-DI:10197106723753 (each) 50197106723751 (case), Lot Number: 7332814 ; 270) PN15LSR14, UDI-DI:10197106723753 (each) 50197106723751 (case), Lot Number: 7331319 ; 271) PN15LSR14, UDI-DI:10197106723753 (each) 50197106723751 (case), Lot Number: 7332923 ; 272) PN15LSR15, UDI-DI:10197106793602 (each) 50197106793600 (case), Lot Number: 7102720 ; 273) PN15LSR15, UDI-DI:10197106793602 (each) 50197106793600 (case), Lot Number: 7332876 ; 274) PN15LSR15, UDI-DI:10197106793602 (each) 50197106793600 (case), Lot Number: 7163123 ; 275) PN15LSRM1, UDI-DI:10195594067021 (each) 50195594067029 (case), Lot Number: J9602R ; 276) PN15LSRM1, UDI-DI:10195594067021 (each) 50195594067029 (case), Lot Number: J8045P ; 277) PN15LSRM1, UDI-DI:10195594067021 (each) 50195594067029 (case), Lot Number: J9197H ; 278) PN15LSRM2, UDI-DI:10195594128050 (each) 50195594128058 (case), Lot Number: 5136036 ; 279) PN15LSRM2, UDI-DI:10195594128050 (each) 50195594128058 (case), Lot Number: 5136012 ; 280) PN15LSRM2, UDI-DI:10195594128050 (each) 50195594128058 (case), Lot Number: J9850D ; 281) PN15LSRM3, UDI-DI:10195594239121 (each) 50195594239129 (case), Lot Number: 5311242 ; 282) PN15LSRM3, UDI-DI:10195594239121 (each) 50195594239129 (case), Lot Number: J9699Y ; 283) PN15LSRM3, UDI-DI:10195594239121 (each) 50195594239129 (case), Lot Number: 5140379 ; 284) PN15LSRM4, UDI-DI:10195594338886 (each) 50195594338884 (case), Lot Number: 5324040 ; 285) PN15LSRM4, UDI-DI:10195594338886 (each) 50195594338884 (case), Lot Number: 5405620 ; 286) PN15LSRM4, UDI-DI:10195594338886 (each) 50195594338884 (case), Lot Number: 5140385 ; 287) PN15LSRM5, UDI-DI:10195594393373 (each) 50195594393371 (case), Lot Number: 5405614 ; 288) PN15LSRM5, UDI-DI:10195594393373 (each) 50195594393371 (case), Lot Number: 5138334 ; 289) PN15LSRM5, UDI-DI:10195594393373 (each) 50195594393371 (case), Lot Number: 5533338 ; 290) PN15LSRM6, UDI-DI:10195594495954 (each) 50195594495952 (case), Lot Number: 5631025 ; 291) PN15LSRM6, UDI-DI:10195594495954 (each) 50195594495952 (case), Lot Number: 5631060 ; 292) PN15LSRM6, UDI-DI:10195594495954 (each) 50195594495952 (case), Lot Number: 5478805 ; 293) PN15LSRM7, UDI-DI:10195594561451 (each) 50195594561459 (case), Lot Number: J53W15 ; 294) PN15LSRM7, UDI-DI:10195594561451 (each) 50195594561459 (case), Lot Number: 5508051 ; 295) PN15LSRM7, UDI-DI:10195594561451 (each) 50195594561459 (case), Lot Number: 5664107 ; 296) PN15LSRM8, UDI-DI:10197106017180 (each) 50197106017188 (case), Lot Number: 6563903 ; 297) PN15LSRM8, UDI-DI:10197106017180 (each) 50197106017188 (case), Lot Number: 6416680 ; 298) PN15LSRM8, UDI-DI:10197106017180 (each) 50197106017188 (case), Lot Number: 6345527 ; 299) PN15LSRM9, UDI-DI:10197106077801 (each) 50197106077809 (case), Lot Number: 6687061 ; 300) PN15LSRM9, UDI-DI:10197106077801 (each) 50197106077809 (case), Lot Number: 6416681 ; 301) PN15LSRM9, UDI-DI:10197106077801 (each) 50197106077809 (case), Lot Number: 6487917 ; 302) PN15LSRMC, UDI-DI:10195594447052 (each) 50195594447050 (case), Lot Number: 5891284 ; 303) PN15LSRMC, UDI-DI:10195594447052 (each) 50195594447050 (case), Lot Number: 5891299 ; 304) PN15LSRMC, UDI-DI:10195594447052 (each) 50195594447050 (case), Lot Number: 5858465 ; 305) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6701937 ; 306) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6701850 ; 307) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6702035 ; 308) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 7005434 ; 309) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 7005438 ; 310) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6748356 ; 311) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6779959 ; 312) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 7005433 ; 313) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6775067 ; 314) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 7160529 ; 315) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 5664021 ; 316) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 5891300 ; 317) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 5970336 ; 318) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 5891292 ; 319) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 5891299 ; 320) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 5664106 ; 321) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6022055 ; 322) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6232004 ; 323) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6025794 ; 324) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6183268 ; 325) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6345511 ; 326) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6025793 ; 327) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 5530907 ; 328) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6416678 ; 329) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6487906 ; 330) PN15LSRME, UDI-DI:10197106409206 (each

Quantity Affected: 973,785 total units

Reason for Recall

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-11-08

Company

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 142 device recalls issued in the same week, part of 413 device-related FDA actions this month.

Cardinal Health 200, LLC has 153 FDA actions in our database, including 152 recalls and 1 clearance.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cardinal Health 200, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Cardinal Health 200, LLC have FDA actions?

Cardinal Health 200, LLC has 153 FDA actions in our database, including 152 recalls and 1 device clearance.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1134-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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