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U.S. Department of Health and Human Services

Class 2 Device Recall Presource Convenience Kit

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 Class 2 Device Recall Presource Convenience Kitsee related information
Date Initiated by FirmOctober 01, 2026
Date PostedNovember 13, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0461-2027
Recall Event ID 100062
Product Classification Neurological tray - Product Code OJG
ProductPresource Convenience kits containing recalled WelMed Extension Tubing Sets ALLIANCE LUMBAR PUNCTURE TRAY 26-0286B 26-0286C 26-0286D CUSTOM LUMBAR PUNCTURE PACK B SAN12LPYHD ENS PONCTION LOMBAIRE CH GRANB SAN30LPGBD FORAMINOTOMY PACK SNE54CNFPA LUMBAR PUNCTURE SBA30LBNHE LUMBAR PUNCTURE 20GX3 5 TRAY 26A8060E 26A8060F 26A8060G LUMBAR PUNCTURE 22GX3 5 26-LP3COA LUMBAR PUNCTURE KIT 26-8061L 26-8061M 26-8061N LUMBAR PUNCTURE PACK SBA30LBNHF LUMBAR PUNCTURE PACK B SAN12LPYHE LUMBAR PUNCTURE TRAY 26-0413F 26-0575F 26A6667H 26A6667I 26A6667J 26B4610H 26B4610I SBA30LBYCC MYELOGRAM LUMBAR TRAY 27-2907H 27-2907J MYELOGRAM PACK SAN5CMPGSG MYELOGRAM TRAY 27-2755A 27-6335A 27-6335B 27-6335C 27-9818A 27-9836A 27-9836B SAFETY LMBR PNCTR 20GX3 5 TRAY 26-9456E 26-9456F 26-9456G 26-9456H SAFETY LP 22GX3 5 ATRAUMATIC 26-LP4SFA SAFETY LP TRAY 26-9079E 26-9079F SAFETY LUMBAR PUNCT:ADULT/PEDS SOP30LP11C SAFETY LUMBAR PUNCTURE 20GX3 5 26-LP1SFA SAFETY LUMBAR PUNCTURE TRAY SOP30LP01C SOP30LP06C SOP30LP11C SOP30LPHRC SAFETY LUMBAR PUNCTURE: ADULT SOP30LP01C SAFETY LUMBAR PUNCTURE:ADULT SOP30LP06C STND CAN LUMBAR PUNCT AD PED SOP30LP11C STND CAN LUMBAR PUNCT ADULT SOP30LP01C STND CAN LUMBAR PUNCTURE SOP30LP06C STND CAN MYELOGRAM TRAY 27-5687A
Code Information 26-0286B UDI-DI 10888439530902 Kit lot 368976 26-0286C UDI-DI 10197106919804 Kit lot 446910 453697 26-0286D UDI-DI 10197106978252 Kit lot 473616 SAN12LPYHD UDI-DI 10197106466032 Kit lots 248082 255134 256005 484940 515017 SAN30LPGBD UDI-DI 10197106663554 Kit lots 292409 326997 351716 380956 483328 658976 701476 770031 SNE54CNFPA UDI-DI 10197106712610 Kit lot 323473 SBA30LBNHE UDI-DI 10197106084304 Kit lot 237175 295385 26A8060E UDI-DI 10888439747966 Kit lot 509302 26A8060F UDI-DI 10197106577073 Kit lots 510205 510253 510873 510963 26A8060G UDI-DI 10197106642894 Kit lots 512844 514059 514060 514061 514062 515637 515969 516353 517030 517205 517293 518538 518539 519395 519858 520050 520929 521111 26-LP3COA UDI-DI 10197106061732 Kit lots 509965 511338 511784 512451 512633 512687 512994 513774 514113 514116 514426 514598 514992 515155 515626 515755 515985 516012 516386 516651 516658 516659 517104 517171 517666 517986 518115 518548 518549 519046 519047 519094 519098 519102 519105 519230 519383 519698 519731 520087 520371 520389 520601 520632 520633 520671 521226 521322 521324 521990 521991 522130 26-8061L UDI-DI 10195594717001 Kit lots 212324 228588 26-8061M UDI-DI 10197106632628 Kit lot 260396 26-8061N UDI-DI 10197106678930 Kit lots 308280 361900 494359 516049 532252 568922 593429 604987 609506 614483 799425 SBA30LBNHF UDI-DI 10197106694954 Kit lots 311717 326546 347597 374619 SAN12LPYHE UDI-DI 10198956087811 Kit lots 562034 579101 599459 679395 707843 721389 753844 26-0413F UDI-DI 10197106401323 Kit lots 509571 510427 510502 511123 512649 512804 513416 514072 515918 516214 516951 517774 518529 518941 520031 520862 521383 26-0575F UDI-DI 10195594867164 Kit lots 188859 258937 264103 267850 271323 278748 543119 576841 614482 650937 720545 799424 26A6667H UDI-DI 10197106496527 Kit lot 235552 26A6667I UDI-DI 10197106600511 Kit lots 248248 271314 275900 26A6667J UDI-DI 10197106659656 Kit lots 340943 459949 26B4610H UDI-DI 10195594767402 Kit lots 312557 349207 373310 404587 428232 434853 452602 26B4610I UDI-DI 10197106981269 Kit lots 474621 533855 SBA30LBYCC UDI-DI 10195594880835 Kit lots 295361 304663 362534 373691 389172 389173 391965 413241 491893 579690 652793 691348 723253 769606 27-2907H UDI-DI 10195594890667 Kit lots 246607 257953 317550 360029 493864 27-2907J UDI-DI 10198956079939 Kit lots 524808 665504 749638 SAN5CMPGSG UDI-DI 10198956007437 Kit lots 517075 520002 27-2755A UDI-DI 10198956208537 Kit lots 519439 519748 27-6335A UDI-DI 10195594777098 Kit lots 509163 510428 510506 511125 511557 512159 512411 512822 513122 513972 514223 514394 514599 514714 514761 514990 515159 515273 515332 515996 517294 518589 519302 519859 27-6335B UDI-DI 10198956309456 Kit lot 520336 27-6335C UDI-DI 10198956355019 Kit lots 520930 521013 521945 27-9818A UDI-DI 10197106985212 Kit lots 516355 517296 517561 517668 517800 518967 519219 519273 27-9836A UDI-DI 10197106015964 Kit lots 509689 509797 510615 510825 511202 511765 512066 512293 512480 513324 516500 516868 516953 517908 520011 520674 521211 27-9836B UDI-DI 10198956483910 Kit lot 521971 26-9456E UDI-DI 10197106585023 Kit lots 237595 249009 26-9456F UDI-DI 10197106647370 Kit lots 314110 360010 388284 398009 442681 455895 482954 528559 26-9456G UDI-DI 10198956150898 Kit lot 579329 26-9456H UDI-DI 10198956182936 Kit lots 624793 645427 720504 26-LP4SFA UDI-DI 10197106061701 Kit lots 512534 512865 513415 514055 514056 514096 514544 514988 515899 516213 516387 516606 516895 517233 517944 517945 518292 518293 518869 519326 519626 519857 520116 521320 522148 26-9079E UDI-DI 10195594698850 Kit lots 250908 322683 353040 381918 419293 428219 449618 462795 488769 26-9079F UDI-DI 10198956047648 Kit lots 524785 562269 617862 631562 675570 721615 746349 766275 SOP30LP11C UDI-DI 10887488563206 Kit lots 201529 216120 26-LP1SFA UDI-DI 10197106061749 Kit lots 509314 509735 509971 509972 509973 510515 510674 510766 510767 511023 511070 511728 511729 511750 511777 511793 511794 512544 512587 512661 512789 513369 513792 514054 514102 514125 514148 514171 514193 514235 514239 514262 514306 514330 514353 514377 514400 514424 514447 514490 515113 515154 515597 515621 515694 515727 515817 515854 516093 516119 516120 516202 516234 516235 516520 516649 516655 516656 516657 516937 516938 517563 517592 517625 517897 517919 517959 518148 518168 518228 518325 518326 518327 518329 518507 518560 518580 518605 518606 518925 518949 518950 518990 519264 519277 519295 519308 519322 519323 519388 519423 519453 519603 519685 519708 519766 519767 519804 519902 519916 519917 520041 520042 520060 520698 520714 520730 520748 520827 520906 520955 521273 521349 521363 521378 521407 521423 521438 521528 521709 521759 521776 SOP30LP01C UDI-DI 10887488563169 Kit lots 558945 564522 581666 SOP30LP06C UDI-DI 10887488563213 Kit lots 558946 786279 786280 SOP30LP11C UDI-DI 10887488563206 Kit lots 608197 776906 SOP30LPHRC UDI-DI 10888439818260 Kit lots 283070 300471 323375 368014 389267 605513 649446 658998 666324 749434 791413 795979 SOP30LP01C UDI-DI 10887488563169 Kit lots 200399 217135 227424 230671 SOP30LP06C UDI-DI 10887488563213 Kit lots 200400 216119 SOP30LP11C UDI-DI 10887488563206 Kit lots 271633 296400 300714 376711 399446 407117 488081 491743 497888 504056 552495 572502 622869 656448 667693 693090 726564 726565 751323 804513 810909 810910 SOP30LP01C UDI-DI 10887488563169 Kit lots 250866 276773 283928 295650 307635 362615 368015 376715 389170 389171 396005 404722 429410 498042 552493 578785 607152 608194 612013 629884 643537 644638 687623 688936 724005 732390 734347 737628 739092 785698 798273 SOP30LP06C UDI-DI 10887488563213 Kit lots 250146 268029 276078 295377 295668 343354 382164 384254 394095 432800 504064 518965 531461 542072 572501 581667 607166 617433 622868 643539 644631 672215 679743 711342 732392 736438 750011 750012 767729 27-5687A UDI-DI 10197106708309 Kit lots 326116
FEI Number 3001236905
Recalling Firm/
Manufacturer
Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
For Additional Information ContactJanna Parks
847-887-1114
Manufacturer Reason
for Recall
Kits include Extension Tubing Sets recalled by supplier WelMed. Affected tubing sets may leak.
FDA Determined
Cause 2
Component design/selection
ActionFirm began notifying customers on October 1, 2026. Prior to use, users should visually inspect the tubing connection area, including bonded junctions and connection points, for any visible irregularities, gaps, deformation, incomplete bonding, leakage, or other abnormalities consistent with the examples shown above. If a defect is observed, or if leakage or connection difficulties are encountered during setup or priming, the product should not be used for patient care and discarded. Customers should report affected product through their normal complaint reporting process and retain the product for evaluation if requested. Direct consignees were instructed to notify retail customers of the market action.
Quantity in Commerce1,155,430
DistributionWorldwide distribution - US Nationwide and the country of Canada.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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