Device product
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
Z-1871-2025
Product summary
- Event
- Event 96783
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1710
- Official record key
device-enforcement:Z-1871-2025
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) 10192253040296; UDI-DI (box) 50192253040294 Lots 2433100060 2433100059 2422700145 2422700139 2422700146 2422700142
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