FDA Device recall Z-2072-2020
Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system
- FDA Device
- Class II
- terminated
- Published 2020-05-27
On 2020-05-27 the FDA classified a Class II recall of Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system by Clinical Innovations, citing there is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2072-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-06 |
| Published | 2020-05-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Clinical Innovations |
| Distribution | n/a |
Product
Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.
Reason
There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system.
Identifiers
| code_info | Model No. VAC-6000MTE, lot no. 181144; UDI: 00814247020659 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2072-2020%22
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