Umbilical Vessel Catheter (Cardinal Health) – Sterility Compromise (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
Brand
Cardinal Health 200, LLC
Lot Codes / Batch Numbers
UDI-DI (ea) 10192253040319
Products Sold
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
Cardinal Health 200, LLC is recalling Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen due to Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Recommended Action
Per FDA guidance
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: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026