FDA Medical devices recall ·
Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen recall
- Recall number
- Z-1875-2025
- Date
- (initiated May 2, 2025)
- Company / brand
- Cardinal Health 200, LLC
3651 Birchwood Dr, Waukegan, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2280
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
Why was it recalled?
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI (ea) 10192253040371; UDI-DI (box) 50192253040379 Lots 2419800006 2335500149
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.
States: Alaska Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Hawaii Iowa Illinois Indiana Kansas Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi North Carolina New Jersey New Mexico New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Dakota Tennessee Texas Utah Virginia Washington Wisconsin West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1875-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.