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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