FDA-Device2025-06-04Class II

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

Cardinal Health 200, LLC
Hazard

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

Sold states
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.
Affected count
1710
Manufactured in
3651 Birchwood Dr, N/A, Waukegan, IL, United States
Products
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1871-2025

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