Class IIOngoingZ-1134-2025

Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1

Cardinal Health 200, LLCWaukegan, IL, United StatesReported Feb 19, 2025 · 1 year ago

By Taylor Coteus

Legal News Analyst · Feb 19, 2025

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC13 3) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC14 4) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC15 5) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC16 6) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC17 7) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC18 8) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC1D 9) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC22 10) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC23 11) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC24 12) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC25 13) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC26 14) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC2C 15) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP32 16) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP33 17) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP34 18) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP3D 19) KIT, VP SHUNT, Catalog Number:P55VNVP09A 20) KIT,ANT CERVICAL DISK,MO BAP, Catalog Number:PGVMACMOQ 21) KIT, CRANIOTOMY, Catalog Number:PN11CNC10 22) KIT, CRANIOTOMY, Catalog Number:PN11CNC11 23) KIT, CRANIOTOMY, Catalog Number:PN11CNC12 24) KIT, CRANIOTOMY, Catalog Number:PN11CNC13 25) KIT, CRANIOTOMY, Catalog Number:PN11CNC14 26) KIT, CRANIOTOMY, Catalog Number:PN11CNC15 27) KIT, CRANIOTOMY, Catalog Number:PN11CNC16 28) KIT, CRANIOTOMY, Catalog Number:PN11CNC17 29) KIT, CRANIOTOMY, Catalog Number:PN11CNC18 30) KIT, CRANIOTOMY, Catalog Number:PN11CNC19 31) KIT, CRANIOTOMY, Catalog Number:PN11CNC20 32) KIT, CRANIOTOMY, Catalog Number:PN11CNCH7 33) KIT, CRANIOTOMY, Catalog Number:PN11CNCH8 34) KIT, CRANIOTOMY, Catalog Number:PN11CNCH9 35) KIT, CRANIOTOMY, Catalog Number:PN11CNCHN 36) KIT, CRANIOTOMY, Catalog Number:PN11CNCHO 37) KIT, CRANIOTOMY, Catalog Number:PN11CNCHQ 38) KIT, CRANIOTOMY, Catalog Number:PN11CNCHR 39) KIT, CRANIOTOMY, Catalog Number:PN11CNCHS 40) KIT, CRANIOTOMY, Catalog Number:PN11CNCHT 41) KIT, CRANIOTOMY, Catalog Number:PN11CNCHU 42) KIT, CRANIOTOMY, Catalog Number:PN11CNCHV 43) KIT, NEURO SJMC, Catalog Number:PN11NEXX2 44) KIT, NEURO SJMC, Catalog Number:PN11NEXX3 45) KIT, NEURO SJMC, Catalog Number:PN11NEXX4 46) KIT, NEURO SJMC, Catalog Number:PN11NEXX5 47) KIT, NEURO SJMC, Catalog Number:PN11NEXX6 48) KIT, NEURO SJMC, Catalog Number:PN11NEXX7 49) KIT, NEURO SJMC, Catalog Number:PN11NEXXB 50) KIT, NEURO SJMC, Catalog Number:PN11NEXXD 51) KIT, NEURO SJMC, Catalog Number:PN11NEXXE 52) KIT, NEURO, Catalog Number:PN11OTR10 53) KIT, NEURO, Catalog Number:PN11OTR11 54) KIT, NEURO, Catalog Number:PN11OTR12 55) KIT, NEURO, Catalog Number:PN11OTR13 56) KIT, NEURO, Catalog Number:PN11OTR14 57) KIT, NEURO, Catalog Number:PN11OTRM1 58) KIT, NEURO, Catalog Number:PN11OTRM2 59) KIT, NEURO, Catalog Number:PN11OTRM3 60) KIT, NEURO, Catalog Number:PN11OTRM4 61) KIT, NEURO, Catalog Number:PN11OTRM5 62) KIT, NEURO, Catalog Number:PN11OTRM7 63) KIT, NEURO, Catalog Number:PN11OTRM8 64) KIT, NEURO, Catalog Number:PN11OTRM9 65) NEURO, KIT, Catalog Number:PN11OTRMQ 66) KIT, NEURO, Catalog Number:PN11OTRMR 67) KIT, NEURO, Catalog Number:PN11OTRMS 68) KIT, NEURO, Catalog Number:PN11OTRMV 69) KIT, NEURO, Catalog Number:PN11OTRMW 70) KIT, SPINAL FUSION, Catalog Number:PN11SHCH5 71) KIT, SPINAL FUSION, Catalog Number:PN11SHCH6 72) KIT, SPINAL FUSION, Catalog Number:PN11SHCH7 73) KIT, SPINAL FUSION, Catalog Number:PN11SHCHQ 74) KIT, SPINAL FUSION, Catalog Number:PN11SHCHR 75) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR10 76) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR11 77) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR12 78) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR13 79) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR14 80) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR15 81) KIT, LARGE SPINE 143487, Catalog Number:PN15LSRM1 82) KIT, LARGE SPINE 143487, Catalog Number:PN15LSRM2 83) KIT, LARGE SP

Lot / code information

UDI: 10195594105471 (each) 50195594105479 (case)
Lot #: J8692J ; 2) CHIP99NC13
UDI: 10195594202378 (each) 50195594202376 (case)
Lot #: 5138245 ; 3) CHIP99NC14
UDI: 10195594276898 (each) 50195594276896 (case)
Lot #: 5324036 ; 4) CHIP99NC15
UDI: 10195594399696 (each) 50195594399694 (case)
Lot #: 5530905 ; 5) CHIP99NC16
UDI: 10195594444846 (each) 50195594444844 (case)
Lot #: 5530911 ; 6) CHIP99NC17

Additional code information

) 50197106409204 (case), Lot Number: 7160474 ; 331) PN15LSRME, UDI-DI:10197106409206 (each) 50197106409204 (case), Lot Number: 7005462 ; 332) PN15LSRME, UDI-DI:10197106409206 (each) 50197106409204 (case), Lot Number: 7160529 ; 333) PN15LSRME, UDI-DI:10197106409206 (each) 50197106409204 (case), Lot Number: 7286185 ; 334) PN15LSRME, UDI-DI:10197106409206 (each) 50197106409204 (case), Lot Number: 7269985 ; 335) PN15LSRME, UDI-DI:10197106409206 (each) 50197106409204 (case), Lot Number: 7266056 ; 336) PN15LSRME, UDI-DI:10197106409206 (each) 50197106409204 (case), Lot Number: 7280044 ; 337) PN15LSRME, UDI-DI:10197106409206 (each) 50197106409204 (case), Lot Number: 7280092 ; 338) PN15LSRME, UDI-DI:10197106409206 (each) 50197106409204 (case), Lot Number: 7320240 ; 339) PN15LSRME, UDI-DI:10197106409206 (each) 50197106409204 (case), Lot Number: 7055826 ; 340) PN15LSRME, UDI-DI:10197106409206 (each) 50197106409204 (case), Lot Number: 7280092 ; 341) PN15LSRME, UDI-DI:10197106409206 (each) 50197106409204 (case), Lot Number: 7320241 ; 342) PN15LSRME, UDI-DI:10197106409206 (each) 50197106409204 (case), Lot Number: 7260073 ; 343) PN15LSRME, UDI-DI:10197106409206 (each) 50197106409204 (case), Lot Number: 7287536 ; 344) PN15LSRME, UDI-DI:10197106409206 (each) 50197106409204 (case), Lot Number: 7331351 ; 345) PN15LSRME, UDI-DI:10197106409206 (each) 50197106409204 (case), Lot Number: 7287471 ; 346) PN15LSRME, UDI-DI:10197106409206 (each) 50197106409204 (case), Lot Number: 7005463 ; 347) PN15LSRME, UDI-DI:10197106409206 (each) 50197106409204 (case), Lot Number: 7331346 ; 348) PN15LSRME, UDI-DI:10197106409206 (each) 50197106409204 (case), Lot Number: 7332838 ; 349) PN15LSRME, UDI-DI:10197106409206 (each) 50197106409204 (case), Lot Number: 7332870 ; 350) PN15LSRME, UDI-DI:10197106409206 (each) 50197106409204 (case), Lot Number: 7349698 ; 351) PN15SSFR1, UDI-DI:10195594211127 (each) 50195594211125 (case), Lot Number: 5138245 ; 352) PN15SSFR1, UDI-DI:10195594211127 (each) 50195594211125 (case), Lot Number: 5138330 ; 353) PN15SSFR2, UDI-DI:10195594310257 (each) 50195594310255 (case), Lot Number: 5508040 ; 354) PN15SSFR2, UDI-DI:10195594310257 (each) 50195594310255 (case), Lot Number: 5405621 ; 355) PN15SSFR3, UDI-DI:10195594381387 (each) 50195594381385 (case), Lot Number: 5405611 ; 356) PN15SSFR3, UDI-DI:10195594381387 (each) 50195594381385 (case), Lot Number: 5138335 ; 357) PN15SSFR4, UDI-DI:10195594426064 (each) 50195594426062 (case), Lot Number: 5530890 ; 358) PN15SSFR4, UDI-DI:10195594426064 (each) 50195594426062 (case), Lot Number: 5533307 ; 359) PN15SSFR4, UDI-DI:10195594426064 (each) 50195594426062 (case), Lot Number: 5533312 ; 360) PN15SSFR5, UDI-DI:10195594500054 (each) 50195594500052 (case), Lot Number: 5631025 ; 361) PN15SSFR5, UDI-DI:10195594500054 (each) 50195594500052 (case), Lot Number: 5508054 ; 362) PN15SSFR6, UDI-DI:10195594781484 (each) 50195594781482 (case), Lot Number: 6185669 ; 363) PN15SSFR6, UDI-DI:10195594781484 (each) 50195594781482 (case), Lot Number: 6345511 ; 364) PN15SSFR7, UDI-DI:10195594876265 (each) 50195594876263 (case), Lot Number: 5530913 ; 365) PN15SSFR7, UDI-DI:10195594876265 (each) 50195594876263 (case), Lot Number: 6232009 ; 366) PN15SSFR8, UDI-DI:10197106478868 (each) 50197106478866 (case), Lot Number: 7163139 ; 367) PN15SSFR8, UDI-DI:10197106478868 (each) 50197106478866 (case), Lot Number: 7269985 ; 368) PN15SSFRA, UDI-DI:10195594957254 (each) 50195594957252 (case), Lot Number: J96N36 ; 369) PN15SSFRA, UDI-DI:10195594957254 (each) 50195594957252 (case), Lot Number: J9424M ; 370) PN15SSFRB, UDI-DI:10195594447458 (each) 50195594447456 (case), Lot Number: J6365M ; 371) PN15SSFRB, UDI-DI:10195594447458 (each) 50195594447456 (case), Lot Number: 5664047 ; 372) PN15SSFRC, UDI-DI:10195594612696 (each) 50195594612694 (case), Lot Number: 6683718 ; 373) PN15SSFRC, UDI-DI:10195594612696 (each) 50195594612694 (case), Lot Number: 6563977 ; 374) PN15SSFRC, UDI-DI:10195594612696 (each) 50195594612694 (case), Lot Number: 6907765 ; 375) PN15SSFRC, UDI-DI:10195594612696 (each) 50195594612694 (case), Lot Number: 6907768 ; 376) PN15SSFRC, UDI-DI:10195594612696 (each) 50195594612694 (case), Lot Number: 6907769 ; 377) PN15SSFRC, UDI-DI:10195594612696 (each) 50195594612694 (case), Lot Number: 6748354 ; 378) PN15SSFRC, UDI-DI:10195594612696 (each) 50195594612694 (case), Lot Number: 6701972 ; 379) PN15SSFRC, UDI-DI:10195594612696 (each) 50195594612694 (case), Lot Number: 6928778 ; 380) PN15SSFRC, UDI-DI:10195594612696 (each) 50195594612694 (case), Lot Number: 7122055 ; 381) PN15SSFRC, UDI-DI:10195594612696 (each) 50195594612694 (case), Lot Number: 7127053 ; 382) PN15SSFRC, UDI-DI:10195594612696 (each) 50195594612694 (case), Lot Number: 7260069 ; 383) PN15SSFRC, UDI-DI:10195594612696 (each) 50195594612694 (case), Lot Number: 7287527 ; 384) PN15SSFRC, UDI-DI:10195594612696 (each) 50195594612694 (case), Lot Number: 5631037 ; 385) PN15SSFRC, UDI-DI:10195594612696 (each) 50195594612694 (case), Lot Number: 5631061 ; 386) PN15SSFRC, UDI-DI:10195594612696 (each) 50195594612694 (case), Lot Number: 6022061 ; 387) PN15SSFRC, UDI-DI:10195594612696 (each) 50195594612694 (case), Lot Number: 6022071 ; 388) PN15SSFRC, UDI-DI:10195594612696 (each) 50195594612694 (case), Lot Number: 6485584 ; 389) PN15SSFRC, UDI-DI:10195594612696 (each) 50195594612694 (case), Lot Number: 6485520 ; 390) PN15SSFRC, UDI-DI:10195594612696 (each) 50195594612694 (case), Lot Number: 6683722 ; 391) PN15SSFRC, UDI-DI:10195594612696 (each) 50195594612694 (case), Lot Number: 6470285 ; 392) PN15SSFRC, UDI-DI:10195594612696 (each) 50195594612694 (case), Lot Number: 6264448 ; 393) PN15SSFRC, UDI-DI:10195594612696 (each) 50195594612694 (case), Lot Number: 6470296 ; 394) PN15SSFRD, UDI-DI:10197106551950 (each) 50197106551958 (case), Lot Number: 7055825 ; 395) PN15SSFRD, UDI-DI:10197106551950 (each) 50197106551958 (case), Lot Number: 7280093 ; 396) PN15SSFRD, UDI-DI:10197106551950 (each) 50197106551958 (case), Lot Number: 7287460 ; 397) PN15SSFRD, UDI-DI:10197106551950 (each) 50197106551958 (case), Lot Number: 7287550 ; 398) PN15SSFRD, UDI-DI:10197106551950 (each) 50197106551958 (case), Lot Number: 7287479 ; 399) PN15SSFRD, UDI-DI:10197106551950 (each) 50197106551958 (case), Lot Number: 7280091 ; 400) PN15SSFRD, UDI-DI:10197106551950 (each) 50197106551958 (case), Lot Number: 7331285 ; 401) PN15SSFRD, UDI-DI:10197106551950 (each) 50197106551958 (case), Lot Number: 7331323 ; 402) PN15SSFRD, UDI-DI:10197106551950 (each) 50197106551958 (case), Lot Number: 6560923 ; 403) PN15SSFRD, UDI-DI:10197106551950 (each) 50197106551958 (case), Lot Number: 7287534 ; 404) PN15SSFRD, UDI-DI:10197106551950 (each) 50197106551958 (case), Lot Number: 7332810 ; 405) PN15SSFRD, UDI-DI:10197106551950 (each) 50197106551958 (case), Lot Number: 7332872 ; 406) PN15SSFRD, UDI-DI:10197106551950 (each) 50197106551958 (case), Lot Number: 7332837 ; 407) PN15SSFRD, UDI-DI:10197106551950 (each) 50197106551958 (case), Lot Number: 7349671 ; 408) PN19CRK10, UDI-DI:10197106306109 (each) 50197106306107 (case), Lot Number: 7005424 ; 409) PN19CRK10, UDI-DI:10197106306109 (each) 50197106306107 (case), Lot Number: 6702004 ; 410) PN19CRK10, UDI-DI:10197106306109 (each) 50197106306107 (case), Lot Number: 6779961 ; 411) PN19CRK11, UDI-DI:10197106480113 (each) 50197106480111 (case), Lot Number: 7163139 ; 412) PN19CRK11, UDI-DI:10197106480113 (each) 50197106480111 (case), Lot Number: 7197963 ; 413) PN19CRK11, UDI-DI:10197106480113 (each) 50197106480111 (case), Lot Number: 7160538 ; 414) PN19CRK12, UDI-DI:10197106541647 (each) 50197106541645 (case), Lot Number: 7280037 ; 415) PN19CRK12, UDI-DI:10197106541647 (each) 50197106541645 (case), Lot Number: 7280097 ; 416) PN19CRK12, UDI-DI:10197106541647 (each) 50197106541645 (case), Lot Number: 7320241 ; 417) PN19CRKH4, UDI-DI:10888439680980 (each) 50888439680988 (case), Lot Number: J53W17 ; 418) PN19CRKH4, UDI-DI:10888439680980 (each) 50888439680988 (case), Lot Number: J53W54 ; 419) PN19CRKH4, UDI-DI:10888439680980 (each) 50888439680988 (case), Lot Number: J4952P ; 420) PN19CRKH5, UDI-DI:10888439851762 (each) 50888439851760 (case), Lot Number: J76N04 ; 421) PN19CRKH5, UDI-DI:10888439851762 (each) 50888439851760 (case), Lot Number: J53W52 ; 422) PN19CRKH5, UDI-DI:10888439851762 (each) 50888439851760 (case), Lot Number: J70X24 ; 423) PN19CRKH6, UDI-DI:10888439894974 (each) 50888439894972 (case), Lot Number: J82K99 ; 424) PN19CRKH6, UDI-DI:10888439894974 (each) 50888439894972 (case), Lot Number: J79H51 ; 425) PN19CRKH6, UDI-DI:10888439894974 (each) 50888439894972 (case), Lot Number: J7963U ; 426) PN19CRKH7, UDI-DI:10195594259457 (each) 50195594259455 (case), Lot Number: 5324046 ; 427) PN19CRKH7, UDI-DI:10195594259457 (each) 50195594259455 (case), Lot Number: 5140306 ; 428) PN19CRKH7, UDI-DI:10195594259457 (each) 50195594259455 (case), Lot Number: 5140379 ; 429) PN19CRKH8, UDI-DI:10195594742003 (each) 50195594742001 (case), Lot Number: 6022051 ; 430) PN19CRKH8, UDI-DI:10195594742003 (each) 50195594742001 (case), Lot Number: 6022075 ; 431) PN19CRKH8, UDI-DI:10195594742003 (each) 50195594742001 (case), Lot Number: 5970335 ; 432) PN19CRKH9, UDI-DI:10197106186794 (each) 50197106186792 (case), Lot Number: 6264449 ; 433) PN19CRKH9, UDI-DI:10197106186794 (each) 50197106186792 (case), Lot Number: 6487895 ; 434) PN19CRKH9, UDI-DI:10197106186794 (each) 50197106186792 (case), Lot Number: 6702035 ; 435) PN19CRKHG, UDI-DI:10888439413595 (each) 50888439413593 (case), Lot Number: J3986C ; 436) PN19CRKHG, UDI-DI:10888439413595 (each) 50888439413593 (case), Lot Number: J37U04 ; 437) PN19CRKHG, UDI-DI:10888439413595 (each) 50888439413593 (case), Lot Number: J30T07 ; 438) PN19CRKHH, UDI-DI:10888439914757 (each) 50888439914755 (case), Lot Number: J8692P ; 439) PN19CRKHH, UDI-DI:10888439914757 (each) 50888439914755 (case), Lot Number: J7905A ; 440) PN19CRKHH, UDI-DI:10888439914757 (each) 50888439914755 (case), Lot Number: J8693M ; 441) PN19CRKHH, UDI-DI:10888439914757 (each) 50888439914755 (case), Lot Number: J96A00 ; 442) PN19CRKHH, UDI-DI:10888439914757 (each) 50888439914755 (case), Lot Number: J9601Y ; 443) PN19CRKHH, UDI-DI:10888439914757 (each) 50888439914755 (case), Lot Number: J6368U ; 444) PN19CRKHI, UDI-DI:10195594177461 (each) 50195594177469 (case), Lot Number: 5405614 ; 445) PN19CRKHI, UDI-DI:10195594177461 (each) 50195594177469 (case), Lot Number: 5405624 ; 446) PN19CRKHI, UDI-DI:10195594177461 (each) 50195594177469 (case), Lot Number: BCS694475049001; 447) PN19CRKHI, UDI-DI:10195594177461 (each) 50195594177469 (case), Lot Number: 5508060 ; 448) PN19CRKHJ, UDI-DI:10195594582883 (each) 50195594582881 (case), Lot Number: 6701940 ; 449) PN19CRKHJ, UDI-DI:10195594582883 (each) 50195594582881 (case), Lot Number: 6487893 ; 450) PN19CRKHJ, UDI-DI:10195594582883 (each) 50195594582881 (case), Lot Number: 7005491 ; 451) PN19CRKHJ, UDI-DI:10195594582883 (each) 50195594582881 (cas …

What the firm is doing

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.

DistributionShow details

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

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus

Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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