Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) K...
FDA Device Recall #Z-1132-2025 — Class II — November 8, 2024
Recall Summary
| Recall Number | Z-1132-2025 |
| 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) 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
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) 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)
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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.