Device product
Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
Z-1874-2025
Product summary
- Event
- Event 96783
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10438
- Official record key
device-enforcement:Z-1874-2025
Official wording
Reason: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Code information: UDI-DI (ea) 10192253040364; UDI-DI (box) 50192253040362 Lots 2424900133 2424900134 2424900135 2435200126 2435200127 2435200129 2435200123 2435200124
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.
Derived failure modes
-
Labeling or packaging
Packaging defect
-
Sterility assurance
Packaging defect may compromise sterility of the product. Use of a non-sterile