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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-0466-2027
Recall Event ID 100062
Product Classification Radiology-diagnostic kit - Product Code OIP
ProductPresource Convenience kits containing recalled WelMed Extension Tubing Sets ARTHROGRAM TRAY SAN23AGDHF MULTI PURPOSE RADIOLOGY PK SANHDRPSM8 SANHDRPSME MYELOGRAM PACK SAN76MYMD1 SAN76MYMD3 SAN76MYMD5 SAN76MYMDB MYELOGRAM TRAY 27-3296G 27-7212I 27-7212K 27-7212L 27-7212M 27-7824C 27-9143H 27-9143I 27-9143J SAN26MYLE4 SAN26MYLEC SAN26MYLED MYELOGRAM TRAY LG 27-1256C MYELOGRAM W NEEDLE DF 27-MY1CODA MYELOGRAM WITHOUT NDL PACK SAN32MYM14 SAN32MYM15 SAN32MYMEH SAFETY MYELOGRAM TRAY 27-9456I
Code Information SAN23AGDHF UDI-DI 10887488503806 Kit lots 518574 518643 SANHDRPSM8 UDI-DI 10197106587119 Kit lot 510336 SANHDRPSME UDI-DI 10197106447970 Kit lots 510852 511350 511688 512205 512317 512901 513338 513809 514136 514137 514562 514848 515567 516633 516634 517039 517282 SAN76MYMD1 UDI-DI 10197106663622 Kit lot 276612 SAN76MYMD3 UDI-DI 10198956019553 Kit lot 487430 SAN76MYMD5 UDI-DI 10198956334922 Kit lot 709689 SAN76MYMDB UDI-DI 10195594718558 Kit lots 323441 376027 401573 425919 620273 634219 647810 678358 27-3296G UDI-DI 10195594558338 Kit lots 293937 297065 388989 406067 460257 478182 479366 496095 557253 581447 617864 654128 699278 703725 27-7212I UDI-DI 10195594712242 Kit lots 232567 267819 288298 322684 346455 388280 406971 411956 419295 432736 457426 479345 497473 524736 27-7212K UDI-DI 10198956185937 Kit lots 618265 646881 671301 27-7212L UDI-DI 10198956388185 Kit lot 738547 27-7212M UDI-DI 10198956437364 Kit lot 766277 27-7824C UDI-DI 10195594780104 Kit lots 255502 533867 581818 617865 623622 631563 27-9143H UDI-DI 10197106575888 Kit lot 510526 27-9143I UDI-DI 10197106600986 Kit lots 510992 511339 511697 512053 512194 512981 513219 517295 517396 517578 518828 27-9143J UDI-DI 10198956274273 Kit lot 520010 SAN26MYLE4 UDI-DI 10198956054394 Kit lot 501451 SAN26MYLEC UDI-DI 10195594763831 Kit lots 391317 480479 SAN26MYLED UDI-DI 10198956103160 Kit lots 565613 604720 694048 727363 741565 776209 792411 27-1256C UDI-DI 10195594766924 Kit lots 511493 511575 512016 512934 514624 516973 518759 518899 518943 519169 519356 519705 27-MY1CODA UDI-DI 10197106061718 Kit lots 185917 228545 260565 299745 333600 347998 370201 398019 428782 440060 453647 521400 524753 558769 616897 673455 712647 763483 SAN32MYM14 UDI-DI 10197106871461 Kit lot 514524 SAN32MYM15 UDI-DI 10198956301221 Kit lot 520209 SAN32MYMEH UDI-DI 10195594173777 Kit lots 509544 509661 509662 509663 510350 510888 510983 511331 511842 513546 513547 513713 514610 514705 515353 515674 515931 516286 516287 516677 516678 517118 517119 517500 517501 517522 518072 518519 518901 519324 519534 519827 520520 520690 520869 520870 521168 27-9456I UDI-DI 10197106427927 Kit lots 388281 585463 622939 744128
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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