Device product
MEDLINE STERILE IRIS SCISSORS CVD/STD REF DYNJ04049 (case) and DYNJ04049H (individual unit)
Z-2024-2024
Product summary
- Event
- Event 94435
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 67811 units
- Official record key
device-enforcement:Z-2024-2024
Official wording
Reason: There is the potential of the tip protector to fall off 4.5" sterile, curved, Iris Scissors
Code information: UDI/DI 10080196847273, Lot Numbers: 23GBV681, 23HBD138, 23IBF254, 23LBJ787
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Singapore, Canada.
Derived failure modes
-
Unknown
There is the potential of the tip protector to fall off 4.5" sterile, curved, Iris Scissors