Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FA
Summary
The FDA issued a Class II for Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Numbe 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-1132-2025
Action Date
2025-02-19
Status
Ongoing
Category
device
Product Description
Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG5 3) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG6 4) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG7 5) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG8 6) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFGM 7) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFGN 8) KIT,CHP SINUS ENDOSCOPY, Catalog Number:PE36ESCHA 9) KIT, SSSC ENT, Catalog Number:PECGOTSN1 10) KIT, SSSC ENT, Catalog Number:PECGOTSN2 11) KIT, SSSC ENT, Catalog Number:PECGOTSN3 12) KIT, SSSC ENT, Catalog Number:PECGOTSNA 13) KIT, SSSC ENT, Catalog Number:PECGOTSNB 14) KIT, SSSC ENT, Catalog Number:PECGOTSNC 15) KIT, SSSC ENT, Catalog Number:PECGOTSND 16) KIT, SSSC ENT, Catalog Number:PECGOTSNE 17) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10O 18) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10P 19) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10Q 20) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10R 21) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10S 22) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10T 23) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA10Y 24) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA110 25) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA112 26) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA113 27) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA114 28) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA115 29) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA116 30) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA117 31) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA118 32) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA119 33) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA120 34) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA121 35) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA123 36) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA124 37) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA125 38) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA126 39) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA127 40) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA128 41) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA129 42) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PEV2OT101 43) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PEV2OT10A 44) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PEV2OT10B 45) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PEV2OT10D 46) KIT, MINOR ENT, MERCY, Catalog Number:PEVNMECHE 47) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PGV2OT10C 48) KIT,ENT SINUS ST LOUIS CHILDRE, Catalog Number:PGVMCLCH1 49) KIT,ENT SINUS ST LOUIS CHILDRE, Catalog Number:PGVMCLCH2 50) KIT,ENT SINUS ST LOUIS CHILDRE, Catalog Number:PGVMCLCH3 51) KIT,ENT SINUS ST LOUIS CHILDRE, Catalog Number:PGVMCLCHA 52) ENDO TRAY SSOP PACK, Catalog Number:SBA23ENPC1 53) ENDO TRAY SSOP PACK, Catalog Number:SBA23ENPC2 54) ENDO TRAY SSOP PACK, Catalog Number:SBA23ENPCB 55) ENDO TRAY SSOP PACK, Catalog Number:SBA23ENPCC 56) ENDO SSOP PACK, Catalog Number:SBA23ENPCD 57) L T P PACK, Catalog Number:SEN11LTCH3 58) L T P PACK, Catalog Number:SEN11LTCH4 59) ENT PACK, Catalog Number:SEN12NSHHT 60) ENT PACK, Catalog Number:SEN12NSHHU 61) ENT, Catalog Number:SEN13ENRU5 62) ENT, Catalog Number:SEN13ENRU6 63) ENT, Catalog Number:SEN13ENRUH 64) NASAL PACK, Catalog Number:SEN13NSCOH 65) NASAL PACK, Catalog Number:SEN13NSCOI 66) RHINOPLASTY NASAL PACK, Catalog Number:SEN13RNNT3 67) RHINOPLASTY NASAL PACK, Catalog Number:SEN13RNNT4 68) RHINOPLASTY NASAL PACK, Catalog Number:SEN13RNNTJ 69) SINUS ENT PACK, Catalog Number:SEN13SNNT1 70) SINUS ENT PACK, Catalog Number:SEN13SNNT2 71) SINUS ENT PACK, Catalog Number:SEN13SNNT3 72) STERILE SINUS ENT PACK, Catalog Number:SEN13SNNTL 73) ENT PACK, Catalog Number:SEN21EPHO1 74) ENT PACK, Catalog Number:SEN21EPHO2 75) ENT PACK, Catalog Number:SEN21EPHO3 76) ENT PACK, Cata
Lot/Code Info: 1) PE29NSFG4, UDI-DI:10195594302870 (each) 50195594302878 (case), Lot Number: 5140385 ; 2) PE29NSFG5, UDI-DI:10195594429980 (each) 50195594429988 (case), Lot Number: 5478805 ; 3) PE29NSFG6, UDI-DI:10195594510046 (each) 50195594510044 (case), Lot Number: 5664108 ; 4) PE29NSFG7, UDI-DI:10197106511206 (each) 50197106511204 (case), Lot Number: 7280115 ; 5) PE29NSFG8, UDI-DI:10197106535981 (each) 50197106535989 (case), Lot Number: 7320240 ; 6) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J3593N ; 7) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J46C07 ; 8) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J4952P ; 9) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J5679N ; 10) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J5679T ; 11) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J7905H ; 12) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 6701854 ; 13) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 7005491 ; 14) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 7266056 ; 15) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 7280114 ; 16) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J84K06 ; 17) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J8693H ; 18) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J8693K ; 19) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J6368Z ; 20) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J9197H ; 21) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J9197H ; 22) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 5841390 ; 23) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 5533340 ; 24) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 6025794 ; 25) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 6487916 ; 26) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 6487917 ; 27) PE36ESCHA, UDI-DI:10197106080856 (each) 50197106080854 (case), Lot Number: 6563985 ; 28) PE36ESCHA, UDI-DI:10197106080856 (each) 50197106080854 (case), Lot Number: 6788522 ; 29) PE36ESCHA, UDI-DI:10197106080856 (each) 50197106080854 (case), Lot Number: 7287564 ; 30) PE36ESCHA, UDI-DI:10197106080856 (each) 50197106080854 (case), Lot Number: 7349687 ; 31) PE36ESCHA, UDI-DI:10197106080856 (each) 50197106080854 (case), Lot Number: 7360443 ; 32) PE36ESCHA, UDI-DI:10197106080856 (each) 50197106080854 (case), Lot Number: 6487899 ; 33) PECGOTSN1, UDI-DI:10195594910358 (each) 50195594910356 (case), Lot Number: J6278X ; 34) PECGOTSN2, UDI-DI:10195594573386 (each) 50195594573384 (case), Lot Number: 5841390 ; 35) PECGOTSN3, UDI-DI:10197106422984 (each) 50197106422982 (case), Lot Number: 7163105 ; 36) PECGOTSNA, UDI-DI:10888439218886 (each) 50888439218884 (case), Lot Number: J30T07 ; 37) PECGOTSNA, UDI-DI:10888439218886 (each) 50888439218884 (case), Lot Number: J46C05 ; 38) PECGOTSNA, UDI-DI:10888439218886 (each) 50888439218884 (case), Lot Number: J4952N ; 39) PECGOTSNB, UDI-DI:10888439649017 (each) 50888439649015 (case), Lot Number: J4952P ; 40) PECGOTSNB, UDI-DI:10888439649017 (each) 50888439649015 (case), Lot Number: J4952U ; 41) PECGOTSNB, UDI-DI:10888439649017 (each) 50888439649015 (case), Lot Number: J5679N ; 42) PECGOTSNC, UDI-DI:10888439809640 (each) 50888439809648 (case), Lot Number: J6050A ; 43) PECGOTSNC, UDI-DI:10888439809640 (each) 50888439809648 (case), Lot Number: J70X23 ; 44) PECGOTSND, UDI-DI:10888439861594 (each) 50888439861592 (case), Lot Number: J84K05 ; 45) PECGOTSND, UDI-DI:10888439861594 (each) 50888439861592 (case), Lot Number: J85W32 ; 46) PECGOTSND, UDI-DI:10888439861594 (each) 50888439861592 (case), Lot Number: J9850D ; 47) PECGOTSND, UDI-DI:10888439861594 (each) 50888439861592 (case), Lot Number: 5140379 ; 48) PECGOTSND, UDI-DI:10888439861594 (each) 50888439861592 (case), Lot Number: 5508060 ; 49) PECGOTSND, UDI-DI:10888439861594 (each) 50888439861592 (case), Lot Number: 5631078 ; 50) PECGOTSND, UDI-DI:10888439861594 (each) 50888439861592 (case), Lot Number: 5533340 ; 51) PECGOTSND, UDI-DI:10888439861594 (each) 50888439861592 (case), Lot Number: 6025793 ; 52) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7331349 ; 53) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7163035 ; 54) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7280115 ; 55) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7320240 ; 56) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7331347 ; 57) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7332919 ; 58) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7320243 ; 59) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7280113 ; 60) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7349697 ; 61) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7349699 ; 62) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 6487917 ; 63) PEV2EA10O, UDI-DI:10888439393095 (each) 50888439393093 (case), Lot Number: J43W11 ; 64) PEV2EA10O, UDI-DI:10888439393095 (each) 50888439393093 (case), Lot Number: J43W11 ; 65) PEV2EA10P, UDI-DI:10888439619102 (each) 50888439619100 (case), Lot Number: J43W11 ; 66) PEV2EA10P, UDI-DI:10888439619102 (each) 50888439619100 (case), Lot Number: J43W12 ; 67) PEV2EA10P, UDI-DI:10888439619102 (each) 50888439619100 (case), Lot Number: J4952X ; 68) PEV2EA10Q, UDI-DI:10888439687897 (each) 50888439687895 (case), Lot Number: J4952Z ; 69) PEV2EA10Q, UDI-DI:10888439687897 (each) 50888439687895 (case), Lot Number: J6278Y ; 70) PEV2EA10Q, UDI-DI:10888439687897 (each) 50888439687895 (case), Lot Number: J8241C ; 71) PEV2EA10R, UDI-DI:10888439941593 (each) 50888439941591 (case), Lot Number: J7708N ; 72) PEV2EA10S, UDI-DI:10888439967425 (each) 50888439967423 (case), Lot Number: J8998N ; 73) PEV2EA10S, UDI-DI:10888439967425 (each) 50888439967423 (case), Lot Number: J7128Y ; 74) PEV2EA10T, UDI-DI:10195594180188 (each) 50195594180186 (case), Lot Number: 5533345 ; 75) PEV2EA10T, UDI-DI:10195594180188 (each) 50195594180186 (case), Lot Number: 5664110 ; 76) PEV2EA10T, UDI-DI:10195594180188 (each) 50195594180186 (case), Lot Number: 5664110 ; 77) PEV2EA10T, UDI-DI:10195594180188 (each) 50195594180186 (case), Lot Number: 5140386 ; 78) PEV2EA10T, UDI-DI:10195594180188 (each) 50195594180186 (case), Lot Number: 6022144 ; 79) PEV2EA10T, UDI-DI:10195594180188 (each) 50195594180186 (case), Lot Number: 6416696 ; 80) PEV2EA10T, UDI-DI:10195594180188 (each) 50195594180186 (case), Lot Number: 6560951 ; 81) PEV2EA10Y, UDI-DI:10197106546734 (each) 50197106546732 (case), Lot Number: 7333439 ; 82) PEV2EA110, UDI-DI:10195594947125 (each) 50195594947123 (case), Lot Number: J7708P ; 83) PEV2EA112, UDI-DI:10195594456498 (each) 50195594456496 (case), Lot Number: 5140387 ; 84) PEV2EA113, UDI-DI:10195594545642 (each) 50195594545640 (case), Lot Number: 5140387 ; 85) PEV2EA114, UDI-DI:10195594813864 (each) 50195594813862 (case), Lot Number: 6025795 ; 86) PEV2EA115, UDI-DI:10195594859602 (each) 50195594859600 (case), Lot Number: 6279861 ; 87) PEV2EA116, UDI-DI:10197106174913 (each) 50197106174911 (case), Lot Number: 6560950 ; 88) PEV2EA117, UDI-DI:10197106258132 (each) 50197106258130 (case), Lot Number: 6702037 ; 89) PEV2EA118, UDI-DI:10197106289266 (each) 50197106289264 (case), Lot Number: 6702037 ; 90) PEV2EA119, UDI-DI:10197106392294 (each) 50197106392292 (case), Lot Number: 6568688 ; 91) PEV2EA120, UDI-DI:10197106429273 (each) 50197106429271 (case), Lot Number: 7005492 ; 92) PEV2EA121, UDI-DI:10197106479285 (each) 50197106479283 (case), Lot Number: 6560950 ; 93) PEV2EA123, UDI-DI:10197106593875 (each) 50197106593873 (case), Lot Number: 7331477 ; 94) PEV2EA124, UDI-DI:10197106615096 (each) 50197106615094 (case), Lot Number: 7331477 ; 95) PEV2EA125, UDI-DI:10197106626955 (each) 50197106626953 (case), Lot Number: 7331478 ; 96) PEV2EA126, UDI-DI:10197106669181 (each) 50197106669189 (case), Lot Number: 7331478 ; 97) PEV2EA127, UDI-DI:10197106674475 (each) 50197106674473 (case), Lot Number: 7333440 ; 98) PEV2EA128, UDI-DI:10197106715673 (each) 50197106715671 (case), Lot Number: 7333440 ; 99) PEV2EA128, UDI-DI:10197106715673 (each) 50197106715671 (case), Lot Number: 7333441 ; 100) PEV2EA129, UDI-DI:10197106739129 (each) 50197106739127 (case), Lot Number: 7333441 ; 101) PEV2OT101, UDI-DI:10195594008024 (each) 50195594008022 (case), Lot Number: J96A02 ; 102) PEV2OT10A, UDI-DI:10888439619072 (each) 50888439619070 (case), Lot Number: J4679J ; 103) PEV2OT10A, UDI-DI:10888439619072 (each) 50888439619070 (case), Lot Number: J4680A ; 104) PEV2OT10B, UDI-DI:10888439688634 (each) 50888439688632 (case), Lot Number: J4950Z ; 105) PEV2OT10B, UDI-DI:10888439688634 (each) 50888439688632 (case), Lot Number: J53W12 ; 106) PEV2OT10B, UDI-DI:10888439688634 (each) 50888439688632 (case), Lot Number: J7412G ; 107) PEV2OT10B, UDI-DI:10888439688634 (each) 50888439688632 (case), Lot Number: J77Z27 ; 108) PEV2OT10B, UDI-DI:10888439688634 (each) 50888439688632 (case), Lot Number: J82M03 ; 109) PEV2OT10B, UDI-DI:10888439688634 (each) 50888439688632 (case), Lot Number: J8393C ; 110) PEV2OT10D, UDI-DI:10888439967401 (each) 50888439967409 (case), Lot Number: J96A01 ; 111) PEVNMECHE, UDI-DI:10887488683201 (each) 50887488683209 (case), Lot Number: J5679T ; 112) PGV2OT10C, UDI-DI:10888439393071 (each) 50888439393079 (case), Lot Number: J4678Z ; 113) PGVMCLCH1, UDI-DI:10888439691290 (each) 50888439691298 (case), Lot Number: J46C12 ; 114) PGVMCLCH2, UDI-DI:10197106459195 (each) 50197106459193 (case), Lot Number: 7160518 ; 115) PGVMCLCH3, UDI-DI:10197106525593 (each) 50197106525591 (case), Lot Number: 7163124 ; 116) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 7360541 ; 117) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 6788692 ; 118) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 7287574 ; 119) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J4220A ; 120) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J43W15 ; 121) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J6022K ; 122) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J6372Z ; 123) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J8241D ; 124) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J4953F ; 125) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J84K11 ; 126) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J87C82 ; 127) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 5136000 ; 128) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 5140389 ; 129) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J6935J ; 130) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J6935H ; 131) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: I2131399 ; 132) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 5664113 ; 133) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J65K18 ; 134) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J65K19 ; 135) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 5876884 ; 136) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 6251077 ; 137) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 6251076 ; 138) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 6560956 ; 139) SBA23ENPC1, UDI-DI:10195594699147 (each) 50195594699145 (case), Lot Number: 6022125 ; 140) SBA23ENPC2, UDI-DI:10195594815240 (each) 50195594815248 (case), Lot Number: 6364779 ; 141) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J34J40 ; 142) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J3986W ; 143) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: 9205151 ; 144) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J3987A ; 145) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J4878A ; 146) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J53W60 ; 147) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J7499K ; 148) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: N/A ; 149) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J79H41 ; 150) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J7905C ; 151) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J8393N ; 152) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J84J98 ; 153) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J85W22 ; 154) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J8693G ; 155) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J9424T ; 156) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J9699W ; 157) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: 5140341 ; 158) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: 5631067 ; 159) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: 5664097 ; 160) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: 5775807 ; 161) SBA23ENPCC, UDI-DI:10195594642099 (each) 50195594642097 (case), Lot Number: 6563985 ; 162) SBA23ENPCC, UDI-DI:10195594642099 (each) 50195594642097 (case), Lot Number: 6702007 ; 163) SBA23ENPCC, UDI-DI:10195594642099 (each) 50195594642097 (case), Lot Number: 6756889 ; 164) SBA23ENPCC, UDI-DI:10195594642099 (each) 50195594642097 (case), Lot Number: 6914937 ; 165) SBA23ENPCC, UDI-DI:10195594642099 (each) 50195594642097 (case), Lot Number: 6914939 ; 166) SBA23ENPCC, UDI-DI:10195594642099 (each) 50195594642097 (case), Lot Number: 6914940 ; 167) SBA23ENPCC, UDI-DI:10195594642099 (each) 50195594642097 (case), Lot Number: 5775809 ; 168) SBA23ENPCC, UDI-DI:10195594642099 (each) 50195594642097 (case), Lot Number: 6416686 ; 169) SBA23ENPCC, UDI-DI:10195594642099 (each) 50195594642097 (case), Lot Number: 6416691 ; 170) SBA23ENPCD, UDI-DI:10197106415375 (each) 50197106415373 (case), Lot Number: 7163032 ; 171) SBA23ENPCD, UDI-DI:10197106415375 (each) 50197106415373 (case), Lot Number: 7280102 ; 172) SBA23ENPCD, UDI-DI:10197106415375 (each) 50197106415373 (case), Lot Number: 7280102 ; 173) SBA23ENPCD, UDI-DI:10197106415375 (each) 50197106415373 (case), Lot Number: 7163102 ; 174) SBA23ENPCD, UDI-DI:10197106415375 (each) 50197106415373 (case), Lot Number: 7331335 ; 175) SBA23ENPCD, UDI-DI:10197106415375 (each) 50197106415373 (case), Lot Number: 7332901 ; 176) SBA23ENPCD, UDI-DI:10197106415375 (each) 50197106415373 (case), Lot Number: 7332898 ; 177) SBA23ENPCD, UDI-DI:10197106415375 (each) 50197106415373 (case), Lot Number: 7360446 ; 178) SEN11LTCH3, UDI-DI:10197106198490 (each) 50197106198498 (case), Lot Number: 6907761 ; 179) SEN11LTCH4, UDI-DI:10197106203798 (each) 50197106203796 (case), Lot Number: 6701894 ; 180) SEN12NSHHT, UDI-DI:10888439281118 (each) 50888439281116 (case), Lot Number: J65K12 ; 181) SEN12NSHHU, UDI-DI:10195594971410 (each) 50195594971418 (case), Lot Number: J9424M ; 182) SEN12NSHHU, UDI-DI:10195594971410 (each) 50195594971418 (case), Lot Number: J9424M ; 183) SEN13ENRU5, UDI-DI:10888439683240 (each) 50888439683248 (case), Lot Number: J4952U ; 184) SEN13ENRU6, UDI-DI:10888439758528 (each) 50888439758526 (case), Lot Number: J53W79 ; 185) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 7163105 ; 186) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 6702034 ; 187) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 6779961 ; 188) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 6788669 ; 189) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 7266056 ; 190) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 7280115 ; 191) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 7331347 ; 192) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 7332921 ; 193) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: J37U13 ; 194) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 7332924 ; 195) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: J46C08 ; 196) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: J5679R ; 197) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: J5679R ; 198) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: J76D61 ; 199) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: J84K05 ; 200) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: J85W31 ; 201) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: J85W32 ; 202) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: J9197G ; 203) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 52602505 ; 204) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: J9602U ; 205) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 202008020-KSH ; 206) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: J9197H ; 207) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 5135998 ; 208) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 5140379 ; 209) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 5533339 ; 210) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 5631078 ; 211) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 5841390 ; 212) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 5533340 ; 213) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 5664106 ; 214) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 6022136 ; 215) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 6264574 ; 216) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 6487916 ; 217) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 6702023 ; 218) SEN13NSCOH, UDI-DI:10888439925470 (each) 50888439925478 (case), Lot Number: 5136019 ; 219) SEN13NSCOH, UDI-DI:10888439925470 (each) 50888439925478 (case), Lot Number: 5140357 ; 220) SEN13NSCOI, UDI-DI:10195594613983 (each) 50195594613981 (case), Lot Number: 5858464 ; 221) SEN13NSCOI, UDI-DI:10195594613983 (each) 50195594613981 (case), Lot Number: 6133661 ; 222) SEN13RNNT3, UDI-DI:10888439751352 (each) 50888439751350 (case), Lot Number: J53W79 ; 223) SEN13RNNT4, UDI-DI:10195594354961 (each) 50195594354969 (case), Lot Number: 5405629 ; 224) SEN13RNNTJ, UDI-DI:10885425604005 (each) 50885425604003 (case), Lot Number: J30T08 ; 225) SEN13RNNTJ, UDI-DI:10885425604005 (each) 50885425604003 (case), Lot Number: J37U13 ; 226) SEN13RNNTJ, UDI-DI:10885425604005 (each) 50885425604003 (case), Lot Number: J43U80 ; 227) SEN13RNNTJ, UDI-DI:10885425604005 (each) 50885425604003 (case), Lot Number: J43U78 ; 228) SEN13RNNTJ, UDI-DI:10885425604005 (each) 50885425604003 (case), Lot Number: 2739AC1 ; 229) SEN13RNNTJ, UDI-DI:10885425604005 (each) 50885425604003 (case), Lot Number: J4952U ; 230) SEN13RNNTJ, UDI-DI:10885425604005 (each) 50885425604003 (case), Lot Number: J53W78 ; 231) SEN13RNNTJ, UDI-DI:10885425604005 (each) 50885425604003 (case), Lot Number: J43U80 ; 232) SEN13RNNTJ, UDI-DI:10885425604005 (each) 50885425604003 (case), Lot Number: J9850D ; 233) SEN13RNNTJ, UDI-DI:10885425604005 (each) 50885425604003 (case), Lot Number: 5140378 ; 234) SEN13RNNTJ, UDI-DI:10885425604005 (each) 50885425604003 (case), Lot Number: 5508060 ; 235) SEN13SNNT1, UDI-DI:10888439756302 (each) 50888439756300 (case), Lot Number: J53W77 ; 236) SEN13SNNT2, UDI-DI:10195594910778 (each) 50195594910776 (case), Lot Number: J6278W ; 237) SEN13SNNT3, UDI-DI:10195594412692 (each) 50195594412690 (case), Lot Number: 5533340 ; 238) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: J30T05 ; 239) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: J37U14 ; 240) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: J43U80 ; 241) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: J46C08 ; 242) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: J4952P ; 243) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: J4952U ; 244) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: J53W78 ; 245) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: J7964A ; 246) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: J7905J ; 247) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: J8693J ; 248) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: J8693M ; 249) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: J6368U ; 250) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: J9602W ; 251) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: 5140357 ; 252) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: 5140385 ; 253) SEN21EPHO1, UDI-DI:10195594918828 (each) 50195594918826 (case), Lot Number: J6368Z ; 254) SEN21EPHO2, UDI-DI:10195594476632 (each) 50195594476630 (case), Lot Number: 5631077 ; 255) SEN21EPHO3, UDI-DI:10195594806651 (each) 50195594806659 (case), Lot Number: 6264574 ; 256) SEN21EPHOA, UDI-DI:10888439974140 (each) 50888439974148 (case), Lot Number: 5136019 ; 257) SEN21EPHOB, UDI-DI:10195594142636 (each) 50195594142634 (case), Lot Number: J98T17 ; 258) SEN21EPHOB, UDI-DI:10195594142636 (each) 50195594142634 (case), Lot Number: J9850D ; 259) SEN21EPHOB, UDI-DI:10195594142636 (each) 50195594142634 (case), Lot Number: 0301B61 ; 260) SEN21EPHOB, UDI-DI:10195594142636 (each) 50195594142634 (case), Lot Number: 5405629 ; 261) SEN21EPHOB, UDI-DI:10195594142636 (each) 50195594142634 (case), Lot Number: 5508060 ; 262) SEN21EPHOB, UDI-DI:10195594142636 (each) 50195594142634 (case), Lot Number: 5664107 ; 263) SEN21EPHOB, UDI-DI:10195594142636 (each) 50195594142634 (case), Lot Number: 5858464 ; 264) SEN21EPHOC, UDI-DI:10195594607159 (each) 50195594607157 (case), Lot Number: 6702023 ; 265) SEN21EPHOC, UDI-DI:10195594607159 (each) 50195594607157 (case), Lot Number: 6788671 ; 266) SEN21EPHOC, UDI-DI:10195594607159 (each) 50195594607157 (case), Lot Number: 7160529 ; 267) SEN21EPHOC, UDI-DI:10195594607159 (each) 50195594607157 (case), Lot Number: 7163149 ; 268) SEN21EPHOC, UDI-DI:10195594607159 (each) 50195594607157 (case), Lot Number: 5970335 ; 269) SEN21EPHOC, UDI-DI:10195594607159 (each) 50195594607157 (case), Lot Number: 5970337 ; 270) SEN21EPHOC, UDI-DI:10195594607159 (each) 50195594607157 (case), Lot Number: 6025793 ; 271) SEN21EPHOC, UDI-DI:10195594607159 (each) 50195594607157 (case), Lot Number: 6560949 ; 272) SEN21EPHOC, UDI-DI:10195594607159 (each) 50195594607157 (case), Lot Number: 6560949 ; 273) SEN21EPHOC, UDI-DI:10195594607159 (each) 50195594607157 (case), Lot Number: 6560949 ; 274) SEN21EPHOD, UDI-DI:10197106459980 (each) 50197106459988 (case), Lot Number: 7160538 ; 275) SEN21EPHOD, UDI-DI:10197106459980 (each) 50197106459988 (case), Lot Number: 7280113 ; 276) SEN21EPHOD, UDI-DI:10197106459980 (each) 50197106459988 (case), Lot Number: 7266056 ; 277) SEN21EPHOD, UDI-DI:10197106459980 (each) 50197106459988 (case), Lot Number: 7280116 ; 278) SEN21EPHOD, UDI-DI:10197106459980 (each) 50197106459988 (case), Lot Number: 7320241 ; 279) SEN21EPHOD, UDI-DI:10197106459980 (each) 50197106459988 (case), Lot Number: 7331346 ; 280) SEN21EPHOD, UDI-DI:10197106459980 (each) 50197106459988 (case), Lot Number: 7280114 ; 281) SEN21EPHOE, UDI-DI:10197106783146 (each) 50197106783144 (case), Lot Number: 7332925 ; 282) SEN23BRDU1, UDI-DI:10195594015176 (each) 50195594015174 (case), Lot Number: J9601Y ; 283) SEN23BRDU2, UDI-DI:10195594205584 (each) 50195594205582 (case), Lot Number: J9699R ; 284) SEN23BRDU3, UDI-DI:10195594289676 (each) 50195594289674 (case), Lot Number: 5140306 ; 285) SEN23BRDU3, UDI-DI:10195594289676 (each) 50195594289674 (case), Lot Number: 5145998 ; 286) SEN23BRDU4, UDI-DI:10195594368913 (each) 50195594368911 (case), Lot Number: 5405624 ; 287) SEN23BRDU5, UDI-DI:10197106242063 (each) 50197106242061 (case), Lot Number: 2291744 ; 288) SEN23BRDU5, UDI-DI:10197106242063 (each) 50197106242061 (case), Lot Number: 6568677 ; 289) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 7349684 ; 290) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: J19G16 ; 291) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: J37U05 ; 292) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: J46A89 ; 293) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 6487895 ; 294) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 6717951 ; 295) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 7110269 ; 296) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 7280095 ; 297) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 7280096 ; 298) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 7280097 ; 299) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 7287558 ; 300) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 7280096 ; 301) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 7331327 ; 302) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: J43U73 ; 303) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 7332891 ; 304) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: J4951X ; 305) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 7672 ; 306) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: J53W55 ; 307) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: J6366T ; 308) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: J6278M ; 309) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: J7704C ; 310) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: J6278M ; 311) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: J8393M ; 312) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: J8393K ; 313) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: J97W47 ; 314) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 5136014 ; 315) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 265166 ; 316) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 5631064 ; 317) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 5664093 ; 318) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 5775805 ; 319) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 20H1983 ; 320) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 201019907SH ; 321) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 5858463 ; 322) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 6025777 ; 323) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 5649225 ; 324) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 6416699 ; 325) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 6279857 ; 326) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 6487896 ; 327) SEN23HN55F, UDI-DI:10887488382647 (each) 50887488382645 (case), Lot Number: J16T59 ; 328) SEN23HN55F, UDI-DI:10887488382647 (each) 50887488382645 (case), Lot Number: J19G21 ; 329) SEN23HN55F, UDI-DI:10887488382647 (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
Waukegan, IL
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-1132-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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