Medical device recalls Moderate risk

Clinical Innovations, LLC recalls Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted f…

Recall date
August 6, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2072-2020
FDA classification
Class II
Brand / firm
Clinical Innovations, LLC
Sold / distributed
OUS customers only.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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