Device product
M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
Z-1570-2023
Product summary
- Event
- Event 92005
- Status
- Terminated
- Classification
- Class II
- Quantity
- 295 units
- Official record key
device-enforcement:Z-1570-2023
Official wording
Reason: The plastic housing on the device may fracture
Code information: UDI/DI: 00850009417022, Lot code C2020
Distribution pattern: US Nationwide distribution in the states of FL, MA, and GA.
Derived failure modes
-
Unknown
The plastic housing on the device may fracture