BEUDAMED
    FDA Recall Open, Classified

    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

    Recall: Z-1132-2025 · Initiated November 8, 2024

    Recall

    Recall Number
    Z-1132-2025
    Event Number
    95947
    Firm
    Cardinal Health 200, LLC
    FEI Number
    3001236905
    Product Code
    OGR
    Status
    Open, Classified
    Root Cause
    Material/Component Contamination
    Initiated
    November 8, 2024
    Posted
    February 10, 2025
    Address
    3651 Birchwood Dr, Waukegan, IL, 60085-8337

    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

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

    Action

    An URGENT: MEDICAL DEVICE CORRECTION OVER LABEL notification letter dated 11/8/24 was sent to customers. If you locate affected product within your facility, please complete the following: 1. QUARANTINE affected kits & ALERT your clinicians of this action 2. AFFIX a WARNING LABEL to the front of each Presource kit so that it is clearly visible to clinicians, instructing them to remove and discard all CODMAN Patties & Strips included with the Presource product. 3. RETURN a copy of the enclosed Acknowledgment Form confirming your receipt of this action and the completion of labeling product via fax to 614.652.9648. Should you have any questions, require additional labels or desire special assistance relating to this recall, please feel free to contact Cardinal Health Quality Systems at 800.292.9332.

    Distribution

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

    Quantity

    973,785 total units