Argyle recallZ-1874-2025 · 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-1874-2025
- Status
- Open, Classified
- Initiated by the company
- May 2, 2025
- Posted by the FDA
- May 29, 2025
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 10438
- Product code
- FOS
- FDA submissions
- K941814
- 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. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
Code information (models, lots, serial numbers)
UDI-DI (ea) 10192253040364; UDI-DI (box) 50192253040362 Lots 2424900133 2424900134 2424900135 2435200126 2435200127 2435200129 2435200123 2435200124
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Argyle 8888160556Cardinal 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-1873-2025 · Open, ClassifiedCatalog No. 8888160341; Umbilical Vessel Catheter 5 French single 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.
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