Device product
Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410A
Z-2706-2024
Product summary
- Event
- Event 94356
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3400 units
- Official record key
device-enforcement:Z-2706-2024
Official wording
Reason: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Code information: a) REF DYKE1410A, UDI/DI 40193489269223 (case), 10193489269222 (unit), Lot Numbers: 22EBO806, 22GBW168, 22IBP461, 22LBC090, 22LBM513, 23BBP271, 23DBM055, 23EBQ913, 23GBI842, 23IBF978, 23KBK768
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.