Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.
Reported: May 27, 2020 Initiated: August 6, 2019 #Z-2072-2020
Product Description
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.
Details
- Recalling Firm
- Clinical Innovations, LLC
- Units Affected
- 2340 Units
- Distribution
- OUS customers only.
- Location
- Murray, UT
Frequently Asked Questions
What product was recalled? ▼
Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.. Recalled by Clinical Innovations, LLC. Units affected: 2340 Units.
Why was this product recalled? ▼
There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 27, 2020. Severity: Moderate. Recall number: Z-2072-2020.
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