Clinical Innovations, LLC: Medical Device Recall in 2020 - (Recall #: Z-2072-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 6, 2019

Date Posted: May 27, 2020

Recall Number: Z-2072-2020

Event ID: 85170

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.

Status: Terminated

Product Quantity: 2340 Units

Code Information:

Model No. VAC-6000MTE, lot no. 181144; UDI: 00814247020659

Distribution Pattern:

OUS customers only.

Voluntary or Mandated:

Voluntary: Firm initiated