Catalog No recalled over sterility concerns

Recall date

May 2, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Cardinal Health 200, LLC recalls Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen

Recall number

Z-1875-2025

FDA classification

Class II

Brand / firm

Cardinal Health 200, LLC

Sold / distributed

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 Afr…

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen