FDA DeviceClass IINotable

FDA Recall: Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Ca

Date: 2026-05-06
Brand: Clinical Innovations, LLC
Category: Medical Device
FDA Class: Class II

Description

Due to complaints of device breakage at the traction force gauge to handle joint.

Hazard

Due to complaints of device breakage at the traction force gauge to handle joint.

Remedy

49,175 devices

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