FDAFDA · Food and drugs·Recall number Z-0915-2025

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

Published January 22, 2025 · Recall initiated: November 8, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer: Cardinal Health 200, LLC
Distributor: Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Lot: Catalog Number 2NE69CNK12, UDI/DI 10195594412845 (EA)50195594412843 (CS), Lot Number 5631070 ; Catalog Number 2NE69CNK12, UDI/DI 10195594412845 (EA)50195594412843 (CS), Lot Number 5530905 ; Catalog Number 2NE69CNK12, UDI/DI 10195594412845 (EA)50195594412843 (CS), Lot Number 5138271 ; Catalog Number 2NE69CNK12, UDI/DI 10195594412845 (EA)50195594412843 (CS), Lot Number 5533340 ; Catalog Number CHIP99NC42, UDI/DI 10195594124007 (EA)50195594124005 (CS), Lot Number 5136018 ; Catalog Number CHIP99NC42, UDI/DI 10195594124007 (EA)50195594124005 (CS), Lot Number 5136034 ; Catalog Number CHIP99NC42, UDI/DI 10195594124007 (EA)50195594124005 (CS), Lot Number 5136012 ; Catalog Number CHIP99NC42, UDI/DI 10195594124007 (EA)50195594124005 (CS), Lot Number 5136019 ; Catalog Number CHIP99NC43, UDI/DI 10195594247867 (EA)50195594247865 (CS), Lot Number 5140342 ; Catalog Number CHIP99NC43, UDI/DI 10195594247867 (EA)50195594247865 (CS), Lot Number 5324034 ; Catalog Number CHIP99NC43, UDI/DI 10195594247867 (EA)50195594247865 (CS), Lot Number 5138327 ; Catalog Number CHIP99NC43, UDI/DI 10195594247867 (EA)50195594247865 (CS), Lot Number 5140378 ; Catalog Number CHIP99NC44, UDI/DI 10195594272777 (EA)50195594272775 (CS), Lot Number 5478803 ; Catalog Number CHIP99NC44, UDI/DI 10195594272777 (EA)50195594272775 (CS), Lot Number 5324048 ; Catalog Number CHIP99NC44, UDI/DI 10195594272777 (EA)50195594272775 (CS), Lot Number 5138335 ; Catalog Number CHIP99NC44, UDI/DI 10195594272777 (EA)50195594272775 (CS), Lot Number 5405629 ; Catalog Number CHIP99NC45, UDI/DI 10195594356156 (EA)50195594356154 (CS), Lot Number 5478804 ; Catalog Number CHIP99NC45, UDI/DI 10195594356156 (EA)50195594356154 (CS), Lot Number 5138222 ; Catalog Number CHIP99NC45, UDI/DI 10195594356156 (EA)50195594356154 (CS), Lot Number 5138325 ; Catalog Number CHIP99NC45, UDI/DI 10195594356156 (EA)50195594356154 (CS), Lot Number 5405629 ; Catalog Number CHIP99NC46, UDI/DI 10197106243367 (EA)50197106243365 (CS), Lot Number 6701852 ; Catalog Number CHIP99NC46, UDI/DI 10197106243367 (EA)50197106243365 (CS), Lot Number 6905475 ; Catalog Number CHIP99NC46, UDI/DI 10197106243367 (EA)50197106243365 (CS), Lot Number 6748352 ; Catalog Number CHIP99NC46, UDI/DI 10197106243367 (EA)50197106243365 (CS), Lot Number 6702036 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6788561 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6928764 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7163104 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7331341 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6928772 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7332910 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J3464F ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J34J41 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J37U06 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J43U77 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J4952D ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J5679H ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J6050D ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J74A27 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196
Risk classification: Class II
Area (FDA): device
Country: United States

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