Device product
Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A
Z-2702-2024
Product summary
- Event
- Event 94356
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 99 units
- Official record key
device-enforcement:Z-2702-2024
Official wording
Reason: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Code information: REF DYNJ909211A, UDI/DI 40195327493234 (case), 10195327493233 (unit), Lot Numbers: 23IBU257, 23KBR755
Distribution pattern: Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
Derived failure modes
-
Unknown
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.