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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-0449-2027
Recall Event ID 100062
Product Classification Orthopedic tray - Product Code OJH
ProductPresource Convenience kits containing recalled WelMed Extension Tubing Sets ARTHROGRAPHY BIOPSY PACK SAN35ABB12 SAN35ABBLC SAN35ABBLD ARTHROGRAPHY PROCEDURE PK MAR35ARBH6 MAR35ARBHK JOINT INJECTION PACK SOP59JPIPB LUMBAR PUNCTURE TRAY SAN55LPSC1 SAN55LPSC2 SAN55LPSCC SAN55LPSCD SAN55LPSCE LUMBAR PUNCTURE TRAY ADULT 26-7556A 26-7556C 26-7556E 26-7556G 26-7556H 26-7556I 26-7556K MYELOGRAM TRAY C MED 27-8425A SHOULDER ARTHROSCOPY PACK SOP31SAOSO SOP31SAOSP SOP31SAOSQ SPINAL TAP TRAY 2 SANHDLPWHA
Code Information SAN35ABB12 UDI-DI 10197106619445 Kit lot 510870 SAN35ABBLC UDI-DI 10888439633887 Kit lot 509826 510339 510497 511976 512319 513411 513913 513914 513936 513937 514276 514497 514675 514810 515671 515982 516098 516638 517245 517477 517840 518337 SAN35ABBLD UDI-DI 10198956162341 Kit lot 518784 518918 518919 519693 519703 520035 520265 520719 520782 521041 521300 521425 MAR35ARBH6 UDI-DI 10197106588314 Kit lot 510372 MAR35ARBHK UDI-DI 10888439633870 Kit lot 510518 510700 511269 511501 512700 512701 512973 513406 513626 513696 514802 515748 515935 516016 516549 516831 517446 518353 518881 518882 519475 519710 519868 520036 521055 SOP59JPIPB UDI-DI 10888439639223 Kit lot 287268 316004 372498 428119 SAN55LPSC1 UDI-DI 10198956057562 Kit lot 503716 SAN55LPSC2 UDI-DI 10198956407206 Kit lot 737766 SAN55LPSCC UDI-DI 10197106126516 Kit lot 216020 SAN55LPSCD UDI-DI 10197106684146 Kit lot 387627 417984 SAN55LPSCE UDI-DI 10197106990452 Kit lot 533020 648860 668176 778915 786832 26-7556A UDI-DI 10197106021439 Kit lot 268704 281040 294973 26-7556C UDI-DI 10197106737620 Kit lot 358919 372242 386776 402540 26-7556E UDI-DI 10197106980170 Kit lot 474616 485004 509965 26-7556G UDI-DI 10198956090903 Kit lot 554280 26-7556H UDI-DI 10198956120693 Kit lot 581445 26-7556I UDI-DI 10198956396029 Kit lot 746957 26-7556K UDI-DI 10198956487710 Kit lot 802565 802591 27-8425A UDI-DI 10197106043615 Kit lot 390635 399853 533818 712610 SOP31SAOSO UDI-DI 10195594583774 Kit lot 295862 326300 385836 475262 479739 554433 587331 SOP31SAOSP UDI-DI 10198956190030 KIt lot 642926 663268 718551 SOP31SAOSQ UDI-DI 10198956417472 Kit lot 747382 764204 SANHDLPWHA UDI-DI 10197106466209 Kit lot 185888 223827 278766 493231 545017 584377 597853 618160 645391
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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