FDA recall Z-2072-2020

Clinical Innovations, LLC · Class II · device

Product

Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.

Reason for recall

There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system.

Distribution

OUS customers only.

Key facts

Status
Terminated
Initiation date
2019-08-06
Report date
2020-05-27
Termination date
2022-09-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Murray, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2072-2020