FDA-Device2024-10-30Class II
Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL CUT DOWN TRA, b) PLASTICS SUTURE TRAY
Hazard
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Affected count
168 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL CUT DOWN TRA, b) PLASTICS SUTURE TRAY
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0150-2025Don't want to check this manually?
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