PlainRecalls
FDA Devices Moderate Class II Ongoing

Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI STD NEURO CRANI OPT 4, Catalog Number: CHIP99NC42; 3) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC43; 4) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC44; 5) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC45; 6) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC46; 7) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC4D; 8) KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJ

Reported: January 22, 2025 Initiated: November 8, 2024 #Z-0915-2025

Product Description

Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI STD NEURO CRANI OPT 4, Catalog Number: CHIP99NC42; 3) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC43; 4) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC44; 5) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC45; 6) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC46; 7) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC4D; 8) KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJU2; 9) KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJUE; 10) KIT, CRANIOTOMY PMH , Catalog Number: PN08CPPCA; 11) KIT, NEURO , Catalog Number: PN11NEXX1; 12) KIT, NEURO , Catalog Number: PN11NEXXA; 13) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBW2; 14) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBW3; 15) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBWG; 16) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBWH; 17) KIT, MAJOR NEURO , Catalog Number: PN21MNEG1; 18) KIT, MAJOR NEURO , Catalog Number: PN21MNEG2; 19) KIT, MAJOR NEURO , Catalog Number: PN21MNEG3; 20) KIT, MAJOR NEURO , Catalog Number: PN21MNEG4; 21) KIT, MAJOR NEURO , Catalog Number: PN21MNEG5; 22) KIT, MAJOR NEURO , Catalog Number: PN21MNEGA; 23) KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCV2; 24) KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCV3; 25) KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCVU; 26) KIT,CRANIOTOMY , Catalog Number: PN23CFAH2; 27) KIT,CRANIOTOMY , Catalog Number: PN23CFAH3; 28) KIT,CRANIOTOMY , Catalog Number: PN23CFAH4; 29) KIT,CRANIOTOMY , Catalog Number: PN23CFAH5; 30) KIT,CRANIOTOMY , Catalog Number: PN23CFAH6; 31) KIT,CRANIOTOMY , Catalog Number: PN23CFAH7; 32) KIT,CRANIOTOMY , Catalog Number: PN23CFAHA; 33) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY731; 34) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY732; 35) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY733; 36) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY734; 37) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY735; 38) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY73B; 39) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73D; 40) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73F; 41) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73G; 42) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73H; 43) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM1; 44) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM2; 45) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM3; 46) KIT,CRANIOTOMY,ANDERSON , Catalog Number: PN23CYAMY; 47) KIT,LAMINECTOMY RF , Catalog Number: PN23LMCVU; 48) KIT, NEURO , Catalog Number: PN23NKME1; 49) KIT, NEURO , Catalog Number: PN23NKMEA; 50) KIT, NEURO , Catalog Number: PN23NKMEB; 51) KIT, NEURO , Catalog Number: PN23NKMEC; 52) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA10; 53) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA11; 54) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA12; 55) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA13; 56) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM3; 57) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM4; 58) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM6; 59) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM7; 60) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAM8; 61) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAM9; 62) NEURO SPINE,ANDERSON,KIT , Catalog Number: PN23SPAMS; 63) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMV; 64) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMW; 65) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMX; 66) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMY; 67) KIT, CRANIOTOMY , Catalog Number: PN29CRA10; 68) KIT, CRANIOTOMY , Catalog Number: PN29CRA11; 69) KIT, CR

Reason for Recall

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

Details

Recalling Firm
Cardinal Health 200, LLC
Units Affected
512,786 total units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Location
Waukegan, IL

Frequently Asked Questions

What product was recalled? ▼
Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI STD NEURO CRANI OPT 4, Catalog Number: CHIP99NC42; 3) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC43; 4) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC44; 5) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC45; 6) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC46; 7) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC4D; 8) KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJU2; 9) KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJUE; 10) KIT, CRANIOTOMY PMH , Catalog Number: PN08CPPCA; 11) KIT, NEURO , Catalog Number: PN11NEXX1; 12) KIT, NEURO , Catalog Number: PN11NEXXA; 13) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBW2; 14) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBW3; 15) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBWG; 16) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBWH; 17) KIT, MAJOR NEURO , Catalog Number: PN21MNEG1; 18) KIT, MAJOR NEURO , Catalog Number: PN21MNEG2; 19) KIT, MAJOR NEURO , Catalog Number: PN21MNEG3; 20) KIT, MAJOR NEURO , Catalog Number: PN21MNEG4; 21) KIT, MAJOR NEURO , Catalog Number: PN21MNEG5; 22) KIT, MAJOR NEURO , Catalog Number: PN21MNEGA; 23) KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCV2; 24) KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCV3; 25) KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCVU; 26) KIT,CRANIOTOMY , Catalog Number: PN23CFAH2; 27) KIT,CRANIOTOMY , Catalog Number: PN23CFAH3; 28) KIT,CRANIOTOMY , Catalog Number: PN23CFAH4; 29) KIT,CRANIOTOMY , Catalog Number: PN23CFAH5; 30) KIT,CRANIOTOMY , Catalog Number: PN23CFAH6; 31) KIT,CRANIOTOMY , Catalog Number: PN23CFAH7; 32) KIT,CRANIOTOMY , Catalog Number: PN23CFAHA; 33) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY731; 34) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY732; 35) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY733; 36) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY734; 37) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY735; 38) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY73B; 39) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73D; 40) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73F; 41) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73G; 42) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73H; 43) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM1; 44) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM2; 45) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM3; 46) KIT,CRANIOTOMY,ANDERSON , Catalog Number: PN23CYAMY; 47) KIT,LAMINECTOMY RF , Catalog Number: PN23LMCVU; 48) KIT, NEURO , Catalog Number: PN23NKME1; 49) KIT, NEURO , Catalog Number: PN23NKMEA; 50) KIT, NEURO , Catalog Number: PN23NKMEB; 51) KIT, NEURO , Catalog Number: PN23NKMEC; 52) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA10; 53) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA11; 54) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA12; 55) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA13; 56) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM3; 57) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM4; 58) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM6; 59) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM7; 60) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAM8; 61) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAM9; 62) NEURO SPINE,ANDERSON,KIT , Catalog Number: PN23SPAMS; 63) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMV; 64) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMW; 65) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMX; 66) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMY; 67) KIT, CRANIOTOMY , Catalog Number: PN29CRA10; 68) KIT, CRANIOTOMY , Catalog Number: PN29CRA11; 69) KIT, CR. Recalled by Cardinal Health 200, LLC. Units affected: 512,786 total units.
Why was this product recalled? ▼
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2025. Severity: Moderate. Recall number: Z-0915-2025.

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