Class 2 Device Recall Presource Convenience Kit

• Date Initiated by Firm: October 01, 2026
• Date Posted: November 13, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0464-2027
• Recall Event ID: 100062
• Product Classification: Arthrogram tray - Product Code OII
• Product: Presource Convenience kits containing recalled WelMed Extension Tubing Sets A 21 ARTHROGRAM SAN29ARCCG ARTHROGRAM 22GX3 5 SPINAL NDL 28-AR1COA ARTHROGRAM JOINT INJEC ASP PK SAN29ARCCH ARTHROGRAM MYELOGRAM TRAY 28-3151B 28-3151D ARTHROGRAM TRAY 28-2755A 28-3641A 28-5418I 28-5425A 28-5425B 28-5430J 28-5551D 28-7824E 28-7824F 28-8391F 28-8425A 28-8805J 28-9818A 28A5420D 28A5420E 28A5420G ARTHROGRAM TRAY 2 28-9436I 28-9436J 28-9436K ARTHROGRAM W SPINAL NDL DF 28-AR1CODA SAFETY ARTHRO 22GX3,5, DF KIT 28-2808E SAFETY ARTHROGRAM 22GX3,5 28-AR1SFA SAFETY ARTHROGRAM TRAY 28-2961G SDI ARTHROGRAM TRAY 28-0879F 28-0879G STND CAN ARTHROGRAM TRAY SOP30AR25C
• Code Information: SAN29ARCCG UDI-DI 10885425719082 Kit lots 240398 278802 311040 323017 377599 416046 450046 473003 511262 535732 583959 605539 639491 683323 703013 28-AR1COA UDI-DI 10197106059661 Kit lots 509672 509869 510246 510551 510947 511080 511663 511679 511680 512187 512334 512364 512632 512675 513067 513068 513087 513088 513268 513325 514030 514031 514174 514175 514225 514232 514308 514459 514608 514653 514692 514760 515160 515635 515818 515855 515890 515916 516131 516682 516683 516697 516698 516791 517173 517685 518449 518791 519024 519025 519096 519100 519112 519113 519251 519252 519287 519384 519678 519749 519938 520350 520460 520600 520771 521321 521323 521325 521326 521328 SAN29ARCCH UDI-DI 10198956375901 Kit lot 735905 28-3151B UDI-DI 10198956124707 Kit lots 518361 520818 28-3151D UDI-DI 10198956432086 Kit lots 521283 521339 28-2755A UDI-DI 10198956208506 Kit lots 519440 519504 28-3641A UDI-DI 10197106624968 Kit lots 511261 512936 513276 28-5418I UDI-DI 10195594766542 Kit lots 233976 275567 279101 318014 346456 415752 419296 462797 482907 537360 541529 592696 612589 635827 640300 702187 732037 28-5425A UDI-DI 10197106247495 Kit lots 509922 510594 511309 511674 512279 513588 513677 516174 517005 519084 519960 28-5425B UDI-DI 10198956369603 Kit lot 520801 28-5430J UDI-DI 10195594703561 Kit lots 238795 291676 375330 424928 453651 462477 491907 593627 606585 650939 673471 676190 685547 761767 28-5551D UDI-DI 10195594707385 Kit lots 239944 245808 257947 330769 404329 411899 422885 449401 454598 466023 480656 494314 539440 571345 580827 640271 702183 720549 738070 749630 766279 28-7824E UDI-DI 10195594729714 Kit lots 236680 268682 309457 312744 357493 388328 412978 443294 447056 486309 558416 571346 583525 592250 609136 652068 28-7824F UDI-DI 10198956307001 Kit lot 698144 28-8391F UDI-DI 10195594717032 Kit lots 236681 284294 315333 337974 360790 388998 412913 415736 427240 453704 466069 524733 544102 547935 581451 641699 667799 681592 759867 28-8425A UDI-DI 10197106043585 Kit lots 240960 268683 297299 309458 323625 351866 382642 400850 419299 445058 482974 524787 583526 650940 712650 28-8805J UDI-DI 10197106151952 Kit lots 271260 293688 315334 360011 383165 397562 413915 415428 422918 447100 493254 545020 569416 576844 584418 623614 641686 674503 706159 754669 28-9818A UDI-DI 10197106691717 Kit lots 514043 514395 514715 515089 515090 515274 515362 516052 516390 516477 28A5420D UDI-DI 10195594704056 Kit lots 509524 511608 511698 512051 513328 514373 514690 516307 28A5420E UDI-DI 10198956042063 Kit lots 516712 516899 28A5420G UDI-DI 10198956088672 Kit lots 517484 518590 519507 519939 520219 28-9436I UDI-DI 10197106598597 Kit lots 238099 252582 28-9436J UDI-DI 10197106665916 Kit lots 290059 293689 358951 414040 417345 449620 454618 462798 491199 530489 536772 557283 594546 632833 693442 706166 28-9436K UDI-DI 10198956369276 Kit lots 752698 753262 770230 786565 28-AR1CODA UDI-DI 10197106059647 Kit lots 255129 289077 344645 350010 400848 411957 419243 449400 453686 465746 468325 601282 673456 699279 712648 763492 28-2808E UDI-DI 10195594699918 Kit lots 243312 266969 299752 310770 364178 395699 403225 416503 419245 441357 490045 530488 547934 571344 583523 609508 630647 667798 704760 726862 759284 28-AR1SFA UDI-DI 10197106059678 Kit lots 509914 509915 509930 509931 512130 512782 512982 513267 513326 513649 514036 514541 514542 514725 515970 516132 516652 516660 516661 516711 517140 517141 517360 518698 518792 518944 519357 519528 519567 519924 520337 520461 520626 520825 520826 521306 521307 521394 521412 28-2961G UDI-DI 10197106497722 Kit lots 235560 273886 354087 383174 427190 441395 491198 536771 569413 702198 732265 28-0879F UDI-DI 10197106343548 Kit lots 257369 273105 312558 360051 391502 430156 453635 457451 491187 517245 539475 557276 579331 594528 614461 641717 692039 728851 28-0879G UDI-DI 10198956382725 Kit lot 756508 SOP30AR25C UDI-DI 10888439902860 Kit lots 241842 277597 296401 304100 348803 372276 396020 401261 414407 608186 643453 644625 679734 732384 770231
• FEI Number: 3001236905
• Recalling Firm/ Manufacturer: Cardinal Health 200, LLC; 3651 Birchwood Dr; Waukegan IL 60085-8337
• For Additional Information Contact: Janna 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: Component design/selection
• Action: Firm 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 Commerce: 1,155,430
• Distribution: Worldwide distribution - US Nationwide and the country of Canada.
• Total Product Life Cycle: TPLC 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.