Kiwi Omni Vacuum Delivery System recall — FDA Z-1945-2026
Due to complaints of device breakage at the traction force gauge to handle joint.
Overview of recall records associated with Clinical Innovations, LLC, including dates, categories and classifications where available.
Classification mix: Class II: 7.
Due to complaints of device breakage at the traction force gauge to handle joint.
Firm received complaints of leaking, black liquid, and black particulates in the product vials.
Firm received complaints of leaking cups, black liquid, and black particulates in the 24% Sucrose Solution.
Firm received complaints of leaking, black liquid, and black particulates in the product vials.
Possible false negative or false positive results. The incorrect sample collection swabs (non-scored) were assembled into assembled into the in vitro diagnostic kits. If the user does not…
An incorrect component used during manufacturing. The uterine manipulator tip support does not have the "notch" required to attach the spacer and or colpotomy cup. This may result in a…
There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system.
This page summarizes recall records in which the official source identifies Clinical Innovations, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.