Argyle recallZ-1873-2025 · Cardinal Health 200, LLC · initiated May 2, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cardinal Health 200, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
FDA root cause category: Package design/selection
What the company is doing
The firm started notifying customers on May 2, 2025 via Urgent Medical Device Product Recall letters. Customers were instructed to remove any devices currently in use. In addition, customers should review their inventory and segregate/quarantine all affected product. If product has been further distributed, the distributor should notify all downstream customers. Customers are asked to return an acknowledgement form whether they have affected product or not. Customers should contact the firm to arrange for return and credit or questions regarding suitable alternative products. For questions related to this recall, please contact the market action team at: [email protected] or call 800-292-9332.
Recall details
- Recall number
- Z-1873-2025
- Status
- Open, Classified
- Initiated by the company
- May 2, 2025
- Posted by the FDA
- May 29, 2025
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 51378
- Product code
- FOS
- FDA submissions
- K130725
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Canada, Chile, Colombia, Singapore, South Africa.
Product description
Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
Code information (models, lots, serial numbers)
UDI-DI (ea) 10192253040319; UDI-DI (box) 50192253040317 Lots 2427700158 2425600066 2433000005 2427700160 2425600067 2425600070 2415100113 2425600071 2427700159 2415100110 2412100093 2433000095 2425600069 2425600077 2415100116 2425600063 2425600074 2415100115 2415100114 2412100096 2425600072 2425600075 2404400061 2425600064 2415100106 2425600076 2415100107 2415100112 2425600073 2425600065 2404400062 2404400065 2415100093 2415100109 2415100111 2433000094
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Argyle 8888160341Cardinal Health 200, LLC · CATHETER, UMBILICAL ARTERY1 recall1 report
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 96783).
- Z-1870-2025 · Open, ClassifiedCatalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
- Z-1871-2025 · Open, ClassifiedCatalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
- Z-1872-2025 · Open, ClassifiedCatalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
- Z-1874-2025 · Open, ClassifiedCatalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
- Z-1875-2025 · Open, ClassifiedCatalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page