Medical device recalls Moderate risk

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. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
Recall number
Z-1874-2025
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. 8888160556; Umbilical Vessel Catheter 5 French dual lumen

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