CLASS II Device recall · Reported 27 May 2020 · FDA Enforcement Report
Kiwi Complete Vacuum Delivery System recalled by Clinical Innovations
Clinical Innovations is recalling Kiwi Complete Vacuum Delivery System. The recall was initiated on 6 Aug 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2072-2020
- FDA event ID
- 85170
- Recalling firm
- Clinical Innovations, Murray, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Aug 2019
- FDA classified
- 21 May 2020
- Reported
- 27 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 6 Aug 2019 | Recall initiated by company | |
| 21 May 2020 | Classified by FDA | +289 days |
| 27 May 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.
Where it was distributed
OUS customers only.
Questions about this recall
Is Kiwi Complete Vacuum Delivery System recalled?
Yes. Clinical Innovations recalled Kiwi Complete Vacuum Delivery System on 6 Aug 2019. The recall is Class II and its status is Terminated. Recall number Z-2072-2020.
Why was it recalled?
There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system.
Which lots are affected?
Model No. VAC-6000MTE, lot no. 181144; UDI: 00814247020659
Where was it sold?
OUS customers only.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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