Z-1874-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 4, 2025
- Initiation Date
- May 2, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10438
Product Description
Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual 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 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.
Code Information
UDI-DI (ea) 10192253040364; UDI-DI (box) 50192253040362 Lots 2424900133 2424900134 2424900135 2435200126 2435200127 2435200129 2435200123 2435200124