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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-0463-2027
Recall Event ID 100062
Product Classification Gynecological laparoscopic kit - Product Code OHD
ProductPresource Convenience kits containing recalled WelMed Extension Tubing Sets MPT HSG IR PACK 41-6606D 41-6606E 41-6606G 41-6606H ULTRASOUND TRAY 41-8095B 41-8095C 41-8095D
Code Information 41-6606D UDI-DI 10197106449301 Kit lots 413943 434835 505458 554305 41-6606E UDI-DI 10198956150164 Kit lot 579365 41-6606G UDI-DI 10198956178304 Kit lot 654119 41-6606H UDI-DI 10198956254107 Kit lot 657225 41-8095B UDI-DI 10195594705220 Kit lots 509564 510534 511507 511604 511858 511948 512047 513402 514008 514343 514863 515284 515450 515657 515895 516022 516648 517326 517438 517464 518601 519068 41-8095C UDI-DI 10198956315044 Kit lot 520383 41-8095D UDI-DI 10198956344327 Kit lot 20647
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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