—#213646

Product

Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen

FDA product code: FOS — Catheter, Umbilical Artery
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K130725
Affected lot / code info: UDI-DI (ea) 10192253040296; UDI-DI (box) 50192253040294 Lots 2433100060 2433100059 2422700145 2422700139 2422700146 2422700142

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.

Root cause (FDA determination)

Package design/selection

Action the firm took

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.

Recalling firm

Firm: Cardinal Health 200, LLC
Address: 3651 Birchwood Dr, Waukegan, Illinois 60085-8337

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2025-05-02
Posted by FDA: 2025-05-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213646. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.