Class IIOngoingZ-1135-2025

Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 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 SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP1E 5) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP22 6) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP23 7) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP24 8) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP2D 9) KIT,LUMBAR LAMINECTOMY, Catalog Number:PN29LMFGA 10) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM4 11) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM5 12) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM6 13) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM7 14) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM8 15) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM9 16) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMA 17) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMB 18) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMC 19) KIT, BACK, Catalog Number:PN33BPC10 20) KIT, BACK, Catalog Number:PN33BPC11 21) KIT, BACK, Catalog Number:PN33BPCR1 22) KIT, BACK, Catalog Number:PN33BPCR2 23) KIT, BACK, Catalog Number:PN33BPCR3 24) KIT, BACK, Catalog Number:PN33BPCR4 25) KIT, BACK, Catalog Number:PN33BPCR5 26) KIT, BACK, Catalog Number:PN33BPCR6 27) KIT, BACK, Catalog Number:PN33BPCR7 28) KIT, BACK, Catalog Number:PN33BPCR8 29) KIT, BACK, Catalog Number:PN33BPCR9 30) KIT, BACK, Catalog Number:PN33BPCRA 31) KIT, BACK, Catalog Number:PN33BPCRB 32) KIT, BACK, Catalog Number:PN33BPCRC 33) KIT, MAJOR SPINE, Catalog Number:PN33MSOCG 34) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOU1 35) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOU2 36) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOUA 37) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOUB 38) KIT, JAMES SPINAL ACCESSORY, Catalog Number:PN33SAOUC 39) KIT, JAMES SPINAL ACCESSORY, Catalog Number:PN33SAOUD 40) KIT, LAMINECTOMY, Catalog Number:PN41LMMYA 41) KIT, MINOR SPINE LG MODULE, Catalog Number:PN69MSGA1 42) KIT, MINOR SPINE LG MODULE, Catalog Number:PN69MSGA2 43) KIT, MINOR SPINE LG MODULE, Catalog Number:PN69MSGA3 44) KIT, MINOR SPINE LG MODULE, Catalog Number:PN69MSGA4 45) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU2 46) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU3 47) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU4 48) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU5 49) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU6 50) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU7 51) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAUJ 52) KIT, SPINE, Catalog Number:PNCGKSPI1 53) KIT, ACDF, Catalog Number:PNMVASNL1 54) KIT, ACDF, Catalog Number:PNMVASNL2 55) KIT, ACDF, Catalog Number:PNMVASNLA 56) KIT, ACDF, Catalog Number:PNMVASNLB 57) KIT, ACDF, Catalog Number:PNMVASNLC 58) KIT, LAMINECTOMY, Catalog Number:PNMVLMNL2 59) KIT, LAMINECTOMY, Catalog Number:PNMVLMNL3 60) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLA 61) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLB 62) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLC 63) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLD 64) KIT, SPINE FUSION, Catalog Number:PNMVSF454 65) KIT, SPINE FUSION, Catalog Number:PNMVSF45A 66) KIT,CRANIOTOMY, Catalog Number:PNOCCRZA1 67) KIT,CRANIOTOMY, Catalog Number:PNOCCRZA2 68) KIT,CRANIOTOMY, Catalog Number:PNOCCRZAA 69) KIT,LAMINECTOMY, Catalog Number:PNOCLAZA1 70) KIT,LAMINECTOMY, Catalog Number:PNOCLAZAA 71) KIT, LAMINECTOMY, Catalog Number:PNOCLAZAB 72) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH11 73) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH12 74) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH13 75) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH14 76) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH15 77) SPINE, HUNTINGTON, Catalog Number:PNOCSPHTU 78) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPHTV 79) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPHTW 80) KIT, ORTHO C

Lot / code information

UDI: 10195594137595 (each) 50195594137593 (case)
Lot #: 5138229 ; 2) CHIP99SP12
UDI: 10195594268466 (each) 50195594268464 (case)
Lot #: 5324036 ; 3) CHIP99SP13
UDI: 10197106271377 (each) 50197106271375 (case)
Lot #: 6907769 ; 4) CHIP99SP1E
UDI: 10888439373226 (each) 50888439373224 (case)
Lot #: 7045815 ; 5) CHIP99SP1E
UDI: 10888439373226 (each) 50888439373224 (case)
Lot #: 7280043 ; 6) CHIP99SP1E

Additional code information

1 (each) 50197106587209 (case), Lot Number: 7333439 ; 331) PNOCSPH11, UDI-DI:10195594305895 (each) 50195594305893 (case), Lot Number: 5372220 ; 332) PNOCSPH12, UDI-DI:10195594614485 (each) 50195594614483 (case), Lot Number: 5775786 ; 333) PNOCSPH13, UDI-DI:10195594745653 (each) 50195594745651 (case), Lot Number: 6022056 ; 334) PNOCSPH14, UDI-DI:10197106172346 (each) 50197106172344 (case), Lot Number: 6701937 ; 335) PNOCSPH15, UDI-DI:10197106646311 (each) 50197106646319 (case), Lot Number: 7331285 ; 336) PNOCSPHTU, UDI-DI:10888439403428 (each) 50888439403426 (case), Lot Number: J4679C ; 337) PNOCSPHTU, UDI-DI:10888439403428 (each) 50888439403426 (case), Lot Number: J4680A ; 338) PNOCSPHTU, UDI-DI:10888439403428 (each) 50888439403426 (case), Lot Number: J53W13 ; 339) PNOCSPHTU, UDI-DI:10888439403428 (each) 50888439403426 (case), Lot Number: J76N04 ; 340) PNOCSPHTU, UDI-DI:10888439403428 (each) 50888439403426 (case), Lot Number: J77Z26 ; 341) PNOCSPHTU, UDI-DI:10888439403428 (each) 50888439403426 (case), Lot Number: J7904P ; 342) PNOCSPHTU, UDI-DI:10888439403428 (each) 50888439403426 (case), Lot Number: J8393A ; 343) PNOCSPHTU, UDI-DI:10888439403428 (each) 50888439403426 (case), Lot Number: J8692R ; 344) PNOCSPHTU, UDI-DI:10888439403428 (each) 50888439403426 (case), Lot Number: J68T48 ; 345) PNOCSPHTV, UDI-DI:10195594930127 (each) 50195594930125 (case), Lot Number: J70X16 ; 346) PNOCSPHTV, UDI-DI:10195594930127 (each) 50195594930125 (case), Lot Number: 5405612 ; 347) PNOCSPHTV, UDI-DI:10195594930127 (each) 50195594930125 (case), Lot Number: 5138236 ; 348) PNOCSPHTV, UDI-DI:10195594930127 (each) 50195594930125 (case), Lot Number: 5631029 ; 349) PNOCSPHTV, UDI-DI:10195594930127 (each) 50195594930125 (case), Lot Number: 5664026 ; 350) PNOCSPHTV, UDI-DI:10195594930127 (each) 50195594930125 (case), Lot Number: 5631036 ; 351) PNOCSPHTV, UDI-DI:10195594930127 (each) 50195594930125 (case), Lot Number: 6264446 ; 352) PNOCSPHTV, UDI-DI:10195594930127 (each) 50195594930125 (case), Lot Number: 6345501 ; 353) PNOCSPHTV, UDI-DI:10195594930127 (each) 50195594930125 (case), Lot Number: 6683719 ; 354) PNOCSPHTV, UDI-DI:10195594930127 (each) 50195594930125 (case), Lot Number: 6701884 ; 355) PNOCSPHTW, UDI-DI:10197106222157 (each) 50197106222155 (case), Lot Number: 6986972 ; 356) PNOCSPHTW, UDI-DI:10197106222157 (each) 50197106222155 (case), Lot Number: 7005445 ; 357) PNOCSPHTW, UDI-DI:10197106222157 (each) 50197106222155 (case), Lot Number: 7005425 ; 358) PNOCSPHTW, UDI-DI:10197106222157 (each) 50197106222155 (case), Lot Number: 7160475 ; 359) PNOCSPHTW, UDI-DI:10197106222157 (each) 50197106222155 (case), Lot Number: 7260064 ; 360) PNOCSPHTW, UDI-DI:10197106222157 (each) 50197106222155 (case), Lot Number: 7280044 ; 361) PNOCSPHTW, UDI-DI:10197106222157 (each) 50197106222155 (case), Lot Number: 7287457 ; 362) PNOCSPHTW, UDI-DI:10197106222157 (each) 50197106222155 (case), Lot Number: 7260073 ; 363) PNOCSPHTW, UDI-DI:10197106222157 (each) 50197106222155 (case), Lot Number: 7287460 ; 364) PNOCSPHTW, UDI-DI:10197106222157 (each) 50197106222155 (case), Lot Number: 7332803 ; 365) PNV2OCC10, UDI-DI:10195594076467 (each) 50195594076465 (case), Lot Number: 5135981 ; 366) PNV2OCC10, UDI-DI:10195594076467 (each) 50195594076465 (case), Lot Number: J8045P ; 367) PNV2OCCP7, UDI-DI:10888439604191 (each) 50888439604199 (case), Lot Number: J4678X ; 368) PNV2OCCP7, UDI-DI:10888439604191 (each) 50888439604199 (case), Lot Number: J4219R ; 369) PNV2OCCP7, UDI-DI:10888439604191 (each) 50888439604199 (case), Lot Number: J43U72 ; 370) PNV2OCCP8, UDI-DI:10888439782066 (each) 50888439782064 (case), Lot Number: J6049R ; 371) PNV2OCCP8, UDI-DI:10888439782066 (each) 50888439782064 (case), Lot Number: J4877K ; 372) PNV2OCCP8, UDI-DI:10888439782066 (each) 50888439782064 (case), Lot Number: N/A ; 373) PNV2OCCP9, UDI-DI:10888439853193 (each) 50888439853191 (case), Lot Number: J76N03 ; 374) PNV2OCCP9, UDI-DI:10888439853193 (each) 50888439853191 (case), Lot Number: J7904X ; 375) PNV2OCCPE, UDI-DI:10888439342789 (each) 50888439342787 (case), Lot Number: J4679U ; 376) PNV2OCCPE, UDI-DI:10888439342789 (each) 50888439342787 (case), Lot Number: J43U72 ; 377) PNV2OCCPE, UDI-DI:10888439342789 (each) 50888439342787 (case), Lot Number: J4679N ; 378) PNV2OCCPE, UDI-DI:10888439342789 (each) 50888439342787 (case), Lot Number: J4877T ; 379) PNV2OCCPF, UDI-DI:10888439617696 (each) 50888439617694 (case), Lot Number: J4950R ; 380) PNV2OCCPF, UDI-DI:10888439617696 (each) 50888439617694 (case), Lot Number: J4877T ; 381) PNV2OCCPF, UDI-DI:10888439617696 (each) 50888439617694 (case), Lot Number: J4950X ; 382) PNV2OCCPF, UDI-DI:10888439617696 (each) 50888439617694 (case), Lot Number: J4877P ; 383) PNV2OCCPF, UDI-DI:10888439617696 (each) 50888439617694 (case), Lot Number: J5678R ; 384) PNV2OCCPF, UDI-DI:10888439617696 (each) 50888439617694 (case), Lot Number: J46A81 ; 385) PNV2OCCPF, UDI-DI:10888439617696 (each) 50888439617694 (case), Lot Number: J6277W ; 386) PNV2OCCPF, UDI-DI:10888439617696 (each) 50888439617694 (case), Lot Number: J65K13 ; 387) PNV2OCCPF, UDI-DI:10888439617696 (each) 50888439617694 (case), Lot Number: J77Z27 ; 388) PNV2OCCPF, UDI-DI:10888439617696 (each) 50888439617694 (case), Lot Number: J8045U ; 389) PNV2OCCPG, UDI-DI:10888439883428 (each) 50888439883426 (case), Lot Number: J7904R ; 390) PNV2OCCPG, UDI-DI:10888439883428 (each) 50888439883426 (case), Lot Number: J8064U ; 391) PNV2OCCPG, UDI-DI:10888439883428 (each) 50888439883426 (case), Lot Number: J7904N ; 392) PNV2OCCPG, UDI-DI:10888439883428 (each) 50888439883426 (case), Lot Number: N/A ; 393) PNV2OCCPG, UDI-DI:10888439883428 (each) 50888439883426 (case), Lot Number: 1210PD1 ; 394) PNV2OCCPG, UDI-DI:10888439883428 (each) 50888439883426 (case), Lot Number: J8045T ; 395) PNV2OCCPG, UDI-DI:10888439883428 (each) 50888439883426 (case), Lot Number: J6786D ; 396) PNV2OCCPG, UDI-DI:10888439883428 (each) 50888439883426 (case), Lot Number: J9602C ; 397) PNV2OCCPG, UDI-DI:10888439883428 (each) 50888439883426 (case), Lot Number: J6910U ; 398) PNV2OCCPG, UDI-DI:10888439883428 (each) 50888439883426 (case), Lot Number: J70X08 ; 399) PNV2OCCPG, UDI-DI:10888439883428 (each) 50888439883426 (case), Lot Number: J9602H ; 400) PNV2OCCPG, UDI-DI:10888439883428 (each) 50888439883426 (case), Lot Number: J9602N ; 401) PNV2OCCPG, UDI-DI:10888439883428 (each) 50888439883426 (case), Lot Number: J9602D ; 402) PNVMCL225, UDI-DI:10888439783933 (each) 50888439783931 (case), Lot Number: J53W06 ; 403) PNVMCL225, UDI-DI:10888439783933 (each) 50888439783931 (case), Lot Number: J6278J ; 404) PNVMCL22Q, UDI-DI:10888439520804 (each) 50888439520802 (case), Lot Number: J37T59 ; 405) PNVMCL22Q, UDI-DI:10888439520804 (each) 50888439520802 (case), Lot Number: J37T97 ; 406) PNVMCL22Q, UDI-DI:10888439520804 (each) 50888439520802 (case), Lot Number: J4219D ; 407) PNVMCL22Q, UDI-DI:10888439520804 (each) 50888439520802 (case), Lot Number: J3986R ; 408) PNVMCL22S, UDI-DI:10888439603927 (each) 50888439603925 (case), Lot Number: J4678Z ; 409) PNVMCL22S, UDI-DI:10888439603927 (each) 50888439603925 (case), Lot Number: J46A83 ; 410) PNVMCL22S, UDI-DI:10888439603927 (each) 50888439603925 (case), Lot Number: J4679H ; 411) PNVMCL22S, UDI-DI:10888439603927 (each) 50888439603925 (case), Lot Number: J4877G ; 412) PNVMCL22S, UDI-DI:10888439603927 (each) 50888439603925 (case), Lot Number: J4950X ; 413) PNVMCL22S, UDI-DI:10888439603927 (each) 50888439603925 (case), Lot Number: J4877N ; 414) PNVMCL22S, UDI-DI:10888439603927 (each) 50888439603925 (case), Lot Number: J4680A ; 415) PNVMCL22S, UDI-DI:10888439603927 (each) 50888439603925 (case), Lot Number: J4877R ; 416) PNVMCL22S, UDI-DI:10888439603927 (each) 50888439603925 (case), Lot Number: J53W12 ; 417) PNVMCL22S, UDI-DI:10888439603927 (each) 50888439603925 (case), Lot Number: J46A81 ; 418) PNVMCL22S, UDI-DI:10888439603927 (each) 50888439603925 (case), Lot Number: J82K97 ; 419) PNVMCL22S, UDI-DI:10888439603927 (each) 50888439603925 (case), Lot Number: J8045P ; 420) PNVMCL22S, UDI-DI:10888439603927 (each) 50888439603925 (case), Lot Number: J8692R ; 421) PNVMCL22S, UDI-DI:10888439603927 (each) 50888439603925 (case), Lot Number: J89C54 ; 422) PNVMCL22S, UDI-DI:10888439603927 (each) 50888439603925 (case), Lot Number: J6365Z ; 423) PNVMCL22S, UDI-DI:10888439603927 (each) 50888439603925 (case), Lot Number: N/A ; 424) PNVMCL22S, UDI-DI:10888439603927 (each) 50888439603925 (case), Lot Number: J89C55 ; 425) PNVMLM227, UDI-DI:10888439784374 (each) 50888439784372 (case), Lot Number: J4953F ; 426) PNVMLM227, UDI-DI:10888439784374 (each) 50888439784372 (case), Lot Number: J28W68 ; 427) PNVMLM228, UDI-DI:10888439859676 (each) 50888439859674 (case), Lot Number: J7708T ; 428) PNVMLM228, UDI-DI:10888439859676 (each) 50888439859674 (case), Lot Number: J55G45 ; 429) PNVMLM22Y, UDI-DI:10888439577266 (each) 50888439577264 (case), Lot Number: J4220A ; 430) PNVMLM22Y, UDI-DI:10888439577266 (each) 50888439577264 (case), Lot Number: J2876R ; 431) PNVMLM22Y, UDI-DI:10888439577266 (each) 50888439577264 (case), Lot Number: J43W16 ; 432) PNVMLM22Y, UDI-DI:10888439577266 (each) 50888439577264 (case), Lot Number: J2876R ; 433) PNVMLM22Y, UDI-DI:10888439577266 (each) 50888439577264 (case), Lot Number: J46C11 ; 434) PNVMLM22Y, UDI-DI:10888439577266 (each) 50888439577264 (case), Lot Number: J2876T ; 435) PNVMLM22Y, UDI-DI:10888439577266 (each) 50888439577264 (case), Lot Number: J43W15 ; 436) PNVMLM22Y, UDI-DI:10888439577266 (each) 50888439577264 (case), Lot Number: J2876T ; 437) PNVMLM22Y, UDI-DI:10888439577266 (each) 50888439577264 (case), Lot Number: J46C12 ; 438) PNVMLM22Y, UDI-DI:10888439577266 (each) 50888439577264 (case), Lot Number: J28W68 ; 439) PNVMLM22Z, UDI-DI:10888439793123 (each) 50888439793121 (case), Lot Number: J4953F ; 440) PNVMLM22Z, UDI-DI:10888439793123 (each) 50888439793121 (case), Lot Number: J28W67 ; 441) PNVMLM22Z, UDI-DI:10888439793123 (each) 50888439793121 (case), Lot Number: J7708T ; 442) PNVMLM22Z, UDI-DI:10888439793123 (each) 50888439793121 (case), Lot Number: J73X03 ; 443) PNVMLM22Z, UDI-DI:10888439793123 (each) 50888439793121 (case), Lot Number: J79Z50 ; 444) PNVMLM22Z, UDI-DI:10888439793123 (each) 50888439793121 (case), Lot Number: J4878C ; 445) PNVMLM22Z, UDI-DI:10888439793123 (each) 50888439793121 (case), Lot Number: J8393Z ; 446) PNVMLM22Z, UDI-DI:10888439793123 (each) 50888439793121 (case), Lot Number: J65K20 ; 447) PO1DOSHA1, UDI-DI:10195594281137 (each) 50195594281135 (case), Lot Number: 5324034 ; 448) PO1DOSHA1, UDI-DI:10195594281137 (each) 50195594281135 (case), Lot Number: 5138330 ; 449) PO1DOSHA2, UDI-DI:10195594325039 (each) 50195594325037 (case), Lot Number: 5324040 ; 450) PO1DOSHA2, UDI-DI:10195594325039 (each) 50195594325037 (case), Lot Number: 5138335 ; 451) PO1DOSHA3, UDI-DI:10197106026311 (each) 501971060263 …

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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