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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-0455-2027
Recall Event ID 100062
Product Classification Ear, nose, and throat surgical tray - Product Code OGR
ProductPresource Convenience kits containing recalled WelMed Extension Tubing Sets EAR PACK SEN59ERK26 SEN59ERK27 SEN59ERK28 SEN59ERKSS SPECIALTY EAR PACK SEN69EPS10 SEN69EPSR9 SEN69EPSRD TYMPANO EAR PK SEN81EANML
Code Information SEN59ERK26 UDI-DI 10197106612453 Kit lot 243355 SEN59ERK27 UDI-DI 10197106997741 Kit lot 467863 SEN59ERK28 UDI-DI 10198956004283 Kit lot 480738 SEN59ERKSS UDI-DI 10197106444375 Kit lots 273178 312345 390345 426610 434039 521475 551900 593448 622098 632939 676474 721867 740026 SEN69EPS10 UDI-DI 10198956038431 Kit lot 492537 SEN69EPSR9 UDI-DI 10197106990001 Kit lot 472009 SEN69EPSRD UDI-DI 10195594618322 Kit lots 293575 359384 417495 530852 618928 652184 703334 SEN81EANML UDI-DI 10197106623381 Kit lots 252727 310323
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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