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-0454-2027
• Recall Event ID: 100062
• Product Classification: Cardiovascular procedure kit - Product Code OEZ
• Product: Presource Convenience kits containing recalled WelMed Extension Tubing Sets BODY INTERVENTIONAL PACK SAN11BIJ11 SAN11BIJ12 SAN11BIJOH SAN11BIJOI SAN11BIJOJ SAN11BIJOK SAN11BIJOL DRAINAGE TRAY CT US CMC SAN29DTUNB IR PROCEDURE TRAY SANBCBIC12 SANBCBIC13 SANBCBICHF SANBCBICHG SANBCBICHH OPEN HEART PACK SCV22OHU24 SCV22OHU27 SCV22OHU28 SCV22OHU29 SCV22OHU30 SCV22OHU31 SCV22OHU33 SCV22OHU34 SCV22OHU35 SCV22OHU36 SCV22OHU37 SCV22OHU38 SCV22OHUME PACK,CT DRAINAGE SCV32CTM15 SCV32CTM16 SCV32CTM17 SCV32CTM18 SCV32CTM19 SCV32CTMUH SPECIAL PROCEDURE PACK SAN51SPJO6 SAN51SPJOB
• Code Information: SAN11BIJ11 UDI-DI 10197106974599 Kit lot 469287 SAN11BIJ12 UDI-DI 10198956265240 Kit lot 655153 SAN11BIJOH UDI-DI 10195594564407 Kit lot 243234 SAN11BIJOI UDI-DI 10197106613672 Kit lots 275701 305418 SAN11BIJOJ UDI-DI 10197106711637 Kit lots 314191 396855 408560 432915 450221 496872 SAN11BIJOK UDI-DI 10198956157361 Kit lots 603284 632319 SAN11BIJOL UDI-DI 10198956254190 Kit lots 686038 715526 742484 SAN29DTUNB UDI-DI 10195594635428 Kit lots 252562 268269 322297 357424 371535 407694 434494 452273 472512 496685 518077 538568 543029 562685 582072 594025 619701 653519 655173 682947 699814 754965 SANBCBIC12 UDI-DI 10197106797976 Kit lot 369085 SANBCBIC13 UDI-DI 10198956243859 Kit lot 649243 SANBCBICHF UDI-DI 10195594264345 Kit lots 233546 295014 305082 SANBCBICHG UDI-DI 10197106740200 Kit lot 410615 SANBCBICHH UDI-DI 10197106885260 Kit lots 466666 481056 515750 552986 599729 674859 716529 727431 SCV22OHU24 UDI-DI 10197106596708 Kit lot 235409 SCV22OHU27 UDI-DI 10197106901281 Kit lot 432377 SCV22OHU28 UDI-DI 10198956053335 Kit lot 500574 SCV22OHU29 UDI-DI 10198956060715 Kit lot 505820 SCV22OHU30 UDI-DI 10198956068810 Kit lot 508714 SCV22OHU31 UDI-DI 10198956073968 Kit lot 515770 SCV22OHU33 UDI-DI 10198956117471 Kit lot 549409 SCV22OHU34 UDI-DI 10198956127449 Kit lot 557720 SCV22OHU35 UDI-DI 10198956235397 Kit lot 643693 SCV22OHU36 UDI-DI 10198956243132 Kit lot 649286 SCV22OHU37 UDI-DI 10198956249899 Kit lot 651198 SCV22OHU38 UDI-DI 10198956488427 Kit lot 791749 SCV22OHUME UDI-DI 10195594322724 Kit lots 270890 296732 382843 397058 424391 582129 598751 620770 626494 670378 673205 682052 682053 SCV32CTM15 UDI-DI 10197106720103 Kit lot 312857 SCV32CTM16 UDI-DI 10197106736500 Kit lot 324441 SCV32CTM17 UDI-DI 10197106759967 Kit lot 344288 SCV32CTM18 UDI-DI 10198956020993 Kit lot 487880 SCV32CTM19 UDI-DI 10198956238992 Kit lot 645565 SCV32CTMUH UDI-DI 10888439635980 Kit lots 270747 386883 464749 574766 599083 SAN51SPJO6 UDI-DI 10198956437449 Kit lot 758157 SAN51SPJOB UDI-DI 10198956308282 Kit lots 708511 726671 734902 748442
• 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.