Device product
Centurion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760; b) STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6; c) DENTAL INSTRUMENT KIT, Product Code DH760
Z-1431-2024
Product summary
- Event
- Event 94136
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2310 units
- Official record key
device-enforcement:Z-1431-2024
Official wording
Reason: 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.
Code information: a) DH760, UDI/DI 20653160237713 (case), 00653160237719 (unit), Lot Numbers: 2023042790; b) 9125ST6, UDI/DI 10653160129257 (case), 00653160129250 (unit), Lot Numbers: 2023060790; c) DH760, UDI/DI 20653160237713 (case), 00653160237719 (unit), Lot Numbers: 2023110990
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Panama, Canada.
Derived failure modes
-
Labeling or packaging
weak seal
-
Sterility assurance
breach of sterility