Cardinal Health 200, LLC: Device Recall

Recall #Z-1872-2025 · 05/02/2025

Class II: Risk

Recall Details

Recall Number
Z-1872-2025
Classification
Class II
Product Type
Device
Recalling Firm
Cardinal Health 200, LLC
Status
Ongoing
Date Initiated
05/02/2025
Location
Waukegan, IL, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
58742

Reason for Recall

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

Product Description

Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen

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.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.