Argyle recallZ-1872-2025 · 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-1872-2025
- Status
- Open, Classified
- Initiated by the company
- May 2, 2025
- Posted by the FDA
- May 29, 2025
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 58742
- 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. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
Code information (models, lots, serial numbers)
UDI-DI (ea) 10192253040302; UDI-DI (box) 50192253040300 Lots 2431300157 2431300158 2431300156 2431300154 2431300153 2433300197 2431300152 2418100101 2433300200 2418300064 2432300069 2417000115 2431800139 2432200143 2432600251 2417000116 2433300199 2418100103 2432300066 2418300063 2433300195 2432600250 2430300087 2433300193 2430300085 2417000113 2433300201 2432200139 2429900138 2412300004 2430300083 2430300086 2430300084 2418100102 2431300155
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Argyle 8888160333Cardinal Health 200, LLC · CATHETER, UMBILICAL ARTERY1 recall7 reports
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-1873-2025 · Open, ClassifiedCatalog No. 8888160341; Umbilical Vessel Catheter 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.
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