FDA-Device2024-04-10Class II
Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905; b) VAGINAL REPAIR KIT, Product Code MNS11505; c) PTCA ADD-ON KIT, Product Code MNS11545; d) INSTRUMENT SET, Product Code SUT21355
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Sold states
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
Affected count
1335 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905; b) VAGINAL REPAIR KIT, Product Code MNS11505; c) PTCA ADD-ON KIT, Product Code MNS11545; d) INSTRUMENT SET, Product Code SUT21355
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1443-2024Don't want to check this manually?
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