Device recall
Z-1945-2026: Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum…
FDA device recall · Class II · Clinical Innovations, LLC
Key facts
| Recall number (Z-number) | Z-1945-2026 |
|---|---|
| Recall event | 98597 |
| Product | Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device designed to provide… |
| Product code | HDB |
| Recalling firm | Clinical Innovations, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K981260 |
| FEI number | 1000220650 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database