Device product
Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYK1012268E1
Z-2705-2024
Product summary
- Event
- Event 94356
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2588 units
- Official record key
device-enforcement:Z-2705-2024
Official wording
Reason: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Code information: a) REF DYK1012268E1, UDI/DI 40884389919089 (case), 10884389919088 (unit), Lot Numbers: 22FBU931, 22HBL619, 22JBG192, 22LBH957, 23CBU467, 23FBS319, 23IBT789, 23KMH977
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.