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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-0460-2027
Recall Event ID 100062
Product Classification Lumbar puncture tray (adult & pediatric) - Product Code PWY
ProductPresource Convenience kits containing recalled WelMed Extension Tubing Sets ADULT LUMBAR PUNCTURE TRAY 26-7824C 26-7824D ADULT LUMBAR TRAY 26-9836A 26-9836C LUMBAR PUNCTURE DF 26-LP3CODA LUMBAR PUNCTURE 18GX3 5 26-LP6COA LUMBAR PUNCTURE PACK SAN40LPSL1 SAN40LPSL3 LUMBAR PUNCTURE PACK LG 26-1256D LUMBAR PUNCTURE PEDIATRIC TRAY 26-1303E 26-1303G 26-1303I 26-1303K 26-1303L LUMBAR PUNCTURE TRAY 26-2755A 26-2755B 26-6326E 26-9818A 26-9818B PEDIATRIC INFANT LUMBAR W NDL 99-LP1COA PEDIATRIC LUMBAR PUNCTURE TRAY 26A4610D PEDIATRIC TRAY 26-6142A SAFETY LP PEDIATRIC 22GX1,5 DF 26-LP2SFDA SAFETY LP PEDIATRIC 22GX1.5 DF 26-LP2SFDA SAFETY LP PEDS 22GX1,5 DF KIT 26-2808F SAFETY LUMBAR PNCT 20GX3.5 ,DF 26-LP1SFDA SAFETY LUMBAR PNCT 22GX3.5 DF 26-LP3SFDA SAFETY LUMBAR PUNCTURE 18GX3 5 26-LP6SFA SAFETY LUMBAR PUNCTURE 22GX3 5 26-LP3SFA SAFETY LUMBAR PUNCTURE TRAY 26-0939A SAFTEY LUMBAR PNCT 20GX3,5, DF 26-LP1SFDA SAFTY LUMB PNCT 22GX3,5 KIT 26A2808G 26A2808H 26A2808I
Code Information 26-7824C UDI-DI 10195594767532 Kit lots 190330 267395 284989 320801 382636 427189 443289 446073 457454 482973 533842 562280 576842 583519 592693 609133 652067 26-7824D UDI-DI 10198956353411 Kit lots 717918 807768 26-9836A UDI-DI 10197106015926 Kit lots 510344 510504 512478 513322 516434 516591 516898 26-9836C UDI-DI 10198956095670 Kit lots 518023 520062 521970 26-LP3CODA UDI-DI 10197106326954 Kit lots 186057 387833 687821 700032 26-LP6COA UDI-DI 10197106328972 Kit lots 514082 514083 514119 514509 514588 515125 515126 515708 515946 516013 516444 516735 517105 518680 518681 519300 519490 520184 520479 520876 521174 521294 521295 SAN40LPSL1 UDI-DI 10198956487437 Kit lot 521699 SAN40LPSL3 UDI-DI 10198956517431 Kit lot 522076 26-1256D UDI-DI 10195594732950 Kit lots 511426 511527 511950 512145 513274 513457 517481 517667 518581 518582 518897 519056 519301 26-1303E UDI-DI 10197106205198 Kit lots 510028 511695 512467 513350 513785 513786 515032 515612 516243 516244 516842 517648 518787 518898 26-1303G UDI-DI 10198956197312 Kit lots 519286 519745 26-1303I UDI-DI 10198956336674 Kit lots 520543 26-1303K UDI-DI 10198956419179 Kit lot 521130 26-1303L UDI-DI 10198956421646 Kit lot 521487 26-2755A UDI-DI 10198956208520 Kit lots 519438 519677 26-2755B UDI-DI 10198956369375 Kit lot 520741 26-6326E UDI-DI 10198956429062 Kit lots 521217 521218 521263 26-9818A UDI-DI 10197106892992 Kit lots 515271 516695 516696 516736 516897 516972 26-9818B UDI-DI 10198956082106 Kit lots 517337 517394 518554 520421 520590 99-LP1COA UDI-DI 10197106326336 Kit lots 508775 510243 510535 511662 512351 512396 520034 520502 520985 521052 521183 521452 521662 522001 522166 26A4610D UDI-DI 10197106458075 Kit lot 511280 26-6142A UDI-DI 10197106729212 Kit lot 512911 26-LP2SFDA UDI-DI 10197106326961 Kit lots 387832 587920 609493 649993 26-LP2SFDA UDI-DI 10197106326961 Kit lots 731826 771268 806419 811016 26-2808F UDI-DI 10197106494134 Kit lots 308279 361855 441427 581444 653284 26-LP1SFDA UDI-DI 10197106326992 Kit lots 779511 804882 26-LP3SFDA UDI-DI 10197106326978 Kit lots 687822 693440 698625 26-LP6SFA UDI-DI 10197106326930 Kit lots 512456 514107 514108 515611 516475 517355 519369 519883 520061 521227 521301 26-LP3SFA UDI-DI 10197106326916 Kit lots 509148 510945 511200 511810 512326 512612 512614 512615 513741 514076 514077 514207 514543 515123 515124 515269 515513 516344 516345 516474 516894 517232 517636 517637 517991 518288 518289 518340 518896 519464 519580 519718 519874 519979 520127 520321 521240 521252 521253 521558 522101 522147 26-0939A UDI-DI 10197106859261 Kit lots 679636 796561 26-LP1SFDA UDI-DI 10197106326992 Kit lots 217027 225959 344643 358146 390633 395697 427188 445056 453685 460255 479323 482906 506876 533817 554293 574325 584300 589172 643199 683527 700970 737051 768685 26A2808G UDI-DI 10197106493144 Kit lots 238823 273130 289872 308281 324935 388310 26A2808H UDI-DI 10197106914151 Kit lots 440023 440717 26A2808I UDI-DI 10197106993941 Kit lots 495749 527711 581446 617863 638061 697003 714273 763530
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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