FDA recall Z-1875-2025

Cardinal Health 200, LLC · Class II · device

Product

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

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.

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2025-05-02
Report date
2025-06-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1875-2025