Device product
Medline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DYKC1289F
Z-2710-2024
Product summary
- Event
- Event 94356
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 160 units
- Official record key
device-enforcement:Z-2710-2024
Official wording
Reason: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Code information: a) REF DYKC1289F, UDI/DI 40195327510917 (case), 10195327510916 (unit), Lot Numbers: 23LBF766
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.