Device product
Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.
Z-2072-2020
Product summary
- Event
- Event 85170
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2340 Units
- Official record key
device-enforcement:Z-2072-2020
Official wording
Reason: There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system.
Code information: Model No. VAC-6000MTE, lot no. 181144; UDI: 00814247020659
Distribution pattern: OUS customers only.
Derived failure modes
-
Unknown
There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system.