Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Kiwi Complete Vacuum Delivery System Recalled by Clinical Innovations, LLC Due to There is a potential for loss of vacuum...

Date: August 6, 2019
Company: Clinical Innovations, LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Clinical Innovations, LLC directly.

Affected Products

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

Quantity: 2340 Units

Why Was This Recalled?

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

Where Was This Sold?

OUS customers only.

About Clinical Innovations, LLC

Clinical Innovations, LLC has 8 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report