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-0452-2027
• Recall Event ID: 100062
• Product Classification: Angiography/angioplasty kit - Product Code OEQ
• Product: Presource Convenience kits containing recalled WelMed Extension Tubing Sets ANGIOGRAPHY DRAPE PACK SAN26ADM28 SAN26ADM30 SAN26ADM31 SAN26ADM32 SAN26ADM33 SAN26ADM34 SAN26ADM35 SAN26ADM37 SAN26ADM38 SAN26ADM39 SAN26ADM40 SAN26ADM41 SAN26ADM42 SAN26ADM43 SAN26ADM44 SAN26ADM45 SAN26ADM46 SAN26ADM47 SAN26ADM48 SAN26ADM49 SAN26ADM50 SAN26ADMHS SAN26ADMHT SAN26ADMHU ANGIOGRAPHY PACK PALI MOMI SAN55ANPMH ARTHROGRAM PROCEDURE TRAY 28-1143D ARTHROGRAM TRAY 28-5420I DIAGNOSTIC RADIOLOGY PACK SAN7ADRPNI SAN7ADRPNJ SAN7ADRPNK IVC ANGIO LIGHT PACK SAN56ALIVA IVC ANGIO PACK SAN56APIV6 SAN56APIV7 SAN56APIVA SAN56APIVB MYELOGRAM PACK SAN5CMPGSF MYELOGRAM TRAY SAN42MGL10 SAN42MGL11 SAN42MGL12 SAN42MGLCC PTC LINE TRAY SAN57PT004 SAN57PT00A
• Code Information: SAN26ADM28 UDI-DI 10197106827727 Kit lot 514093 SAN26ADM30 UDI-DI 10197106941447 Kit lot 515573 SAN26ADM31 UDI-DI 10197106889589 Kit lot 514927 SAN26ADM32 UDI-DI 10197106944622 Kit lot 515615 SAN26ADM33 UDI-DI 10198956025233 Kit lot 516462 SAN26ADM34 UDI-DI 10198956025431 Kit lot 516461 SAN26ADM35 UDI-DI 10198956114708 Kit lot 517770 SAN26ADM37 UDI-DI 10198956234031 Kit lot 519574 SAN26ADM38 UDI-DI 10198956238541 Kit lot 519592 SAN26ADM39 UDI-DI 10198956243712 Kit lot 519645 SAN26ADM40 UDI-DI 10198956269545 Kit lot 519840 SAN26ADM41 UDI-DI 10198956269804 Kit lot 519839 SAN26ADM42 UDI-DI 10198956289628 Kit lot 520070 SAN26ADM43 UDI-DI 10198956304529 Kit lot 520256 SAN26ADM44 UDI-DI 10198956308527 Kit lot 520255 SAN26ADM45 UDI-DI 10198956313064 Kit lot 520330 SAN26ADM46 UDI-DI 10198956323025 Kit lot 520398 SAN26ADM47 UDI-DI 10198956336414 Kit lot 520441 SAN26ADM48 UDI-DI 10198956412156 Kit lot 521023 SAN26ADM49 UDI-DI 10198956419636 Kit lot 521092 SAN26ADM50 UDI-DI 10198956421134 Kit lot 521091 SAN26ADMHS UDI-DI 10197106373545 Kit lots 509452 510298 510299 510445 510451 510567 510812 510813 510836 510887 510919 511241 511416 511417 511466 511713 511844 511970 511971 512469 512470 SAN26ADMHT UDI-DI 10197106734803 Kit lots 512732 512922 513020 513116 513244 513881 513915 513916 513944 514331 514332 514413 514685 515449 515651 516303 516864 516995 SAN26ADMHU UDI-DI 10198956082694 Kit lots 517347 517427 518331 518536 518537 518722 518723 519023 519072 519073 519339 519987 520129 520130 520176 520194 520776 520777 520853 520854 520922 520923 SAN55ANPMH UDI-DI 10197106781227 Kit lots 383020 451546 484441 500308 504768 538534 572605 635887 665600 763562 28-1143D UDI-DI 10195594687519 Kit lots 509918 510757 511281 511383 511786 511852 512160 512870 514042 514164 514322 514658 515102 515316 515711 516409 516410 516815 517492 517493 518296 518297 519303 519610 520051 520817 521142 28-5420I UDI-DI 10195594697037 Kit lots 510318 510479 510665 515827 517049 517193 519313 519441 519506 SAN7ADRPNI UDI-DI 10888439979848 Kit lots 280112 382298 478781 519825 530108 543925 548938 554011 579062 601360 SAN7ADRPNJ UD-DI 10198956173040 Kit lots 644107 693118 SAN7ADRPNK UDI-DI 10198956338937 Kit lots 728505 768130 790554 SAN56ALIVA UDI-DI 10888439957273 Kit lots 242345 311182 358478 SAN56APIV6 UDI-DI 10197106993385 Kit lot 477730 SAN56APIV7 UDI-DI 10198956037410 Kit lot 494829 SAN56APIVA UDI-DI 10888439957297 Kit lot 292165 347152 366089 377451 SAN56APIVB UDI-DI 10197106805770 Kit lots 509585 555003 593067 609812 628952 648835 714395 SAN5CMPGSF UDI-DI 10887488561363 Kit lots 511164 511798 511944 512772 513295 513506 513859 514364 515397 515844 SAN42MGL10 UDI-DI 10197106563854 Kit lot 509939 SAN42MGL11 UDI-DI 10197106662182 Kit lot 511589 SAN42MGL12 UDI-DI 10197106667255 Kit lot 511668 SAN42MGLCC UDI-DI 10195594657345 Kit lots 509576 511491 512172 512521 518375 519165 519624 519854 520587 SAN57PT004 UDI-DI 10197106658031 Kit lot 273066 SAN57PT00A UDI-DI 10195594682033 Kit lots 200381 235589 257334
• 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.