Clinical Innovations, LLC is recalling 49,175 Kiwi Omni Vacuum Delivery Systems (Model VAC-6000MT) because the device can break at the joint between the traction force gauge and the handle. This vacuum-assisted system is a single-use tool used by medical professionals to assist in childbirth. The company has received complaints regarding this breakage, which could disrupt the delivery process. This recall affects specific lot numbers distributed worldwide and across many U.S. states.
The device can break at the traction force gauge to handle joint during use. If the device fails during a vacuum-assisted delivery, it could lead to a delay in childbirth or require alternative medical interventions, potentially impacting the safety of both the mother and the infant.
Disposable vacuum assisted fetal delivery system; sterile, single-patient-use device.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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