Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI S...
FDA Device Recall #Z-1134-2025 — Class II — November 8, 2024
Recall Summary
| Recall Number | Z-1134-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 8, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cardinal Health 200, LLC |
| Location | Waukegan, IL |
| Product Type | Devices |
| Quantity | 973,785 total units |
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
Reason for Recall
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Lot / Code Information
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
Other Recalls from Cardinal Health 200, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1203-2026 | Class II | Chest Drainage Units and Accessories: Produc... | Dec 26, 2025 |
| Z-0897-2026 | Class II | ChemoPlus gowns: Product Code Product Descript... | Nov 12, 2025 |
| Z-0207-2026 | Class II | Salem Sump PVC Tubes: Product Code/Product N... | Sep 18, 2025 |
| Z-0208-2026 | Class II | Salem Sump PVC Tubes: Product Code/Product N... | Sep 18, 2025 |
| Z-0211-2026 | Class II | Salem Sump PVC Tubes: Product Code/Product N... | Sep 18, 2025 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.