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-0465-2027
• Recall Event ID: 100062
• Product Classification: Radiographic contrast tray - Product Code OIO
• Product: Presource Convenience kits containing recalled WelMed Extension Tubing Sets IR SPECIAL PACK SAN73IRJC1 SAN73IRJC2 SAN73IRJC3 SAN73IRJC5 SAN73IRJC6 SAN73IRJC7 SAN73IRJC8 SAN73IRJC9 SAN73IRJCA SAN73IRJCB MYELOGRAM ARTHROGRAM TRAY 27-7531E MYELOGRAM II PACK SAN41MTHMA SAN41MTHMB MYELOGRAM TRAY 27-0722G 27-0722H RADIOLOGY PROCEDURE PACK 41-0532E 41-0532F
• Code Information: SAN73IRJC1 UDI-DI 10197106940396 Kit lot 451417 SAN73IRJC2 UDI-DI 10198956116245 Kit lot 548858 SAN73IRJC3 UDI-DI 10198956131668 Kit lot 560690 SAN73IRJC5 UDI-DI 10198956252851 Kit lot 651915 SAN73IRJC6 UDI-DI 10198956267190 Kit lot 662732 SAN73IRJC7 UDI-DI 10198956282452 Kit lot 675388 SAN73IRJC8 UDI-DI 10198956315761 Kit lot 702876 SAN73IRJC9 UDI-DI 10198956373471 Kit lot 723744 SAN73IRJCA UDI-DI 10197106799253 Kit lots 395797 425148 529837 606168 615098 620447 688228 SAN73IRJCB UDI-DI 10198956327498 Kit lots 743507 757083 757832 27-7531E UDI-DI 10195594712495 Kit lots 286748 368357 396790 399893 412923 419276 432662 458844 543120 597861 629382 645409 746339 762283 SAN41MTHMA UDI-DI 10888439635645 Kit lots 359818 442460 463684 465389 487989 596461 628974 672810 702964 SAN41MTHMB UDI-DI 10198956409613 Kit lot 744495 27-0722G UDI-DI 10197106493151 Kit lots 230488 248267 310130 374292 404288 443048 483867 517251 605745 631531 665068 27-0722H UDI-DI 10198956326170 Kit lots 713307 752697 41-0532E UDI-DI 10195594724368 Kit lots 269719 294015 346479 382489 384109 41-0532F UDI-DI 10197106793022 Kit lots 408335 417340 441388 569445 599562 628149 641723 690286 706157 713238 732036 745511
• 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.