Clinical Innovations, LLC recalls Brand Name: Kiwi Omni Vacuum Delivery System Product Name: K
See all recalls from Clinical Innovations, LLC →Recalled 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 assistance in childbirth under the following conditions: 1) Term pregnancy, 2) Ruptured amniotic membranes, 3) Engaged head, 4) Complete cervical dilation, and 5) Adequately trained or supervised operator.
Hazard / Issue
Due to complaints of device breakage at the traction force gauge to handle joint.
Issued by
FDA
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
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Search Amazon for Brand Name: Kiwi Omni →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
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