Recall Z-1945-2026— Clinical Innovations, LLC
Class II · Ongoing
Class II FDA medical device recall by Clinical Innovations, LLC, initiated 2026-03-09. It names one FDA 510(k) clearance: K981260. 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.. Reason: Due to complaints of device breakage at the traction force gauge to handle joint..
- Recalling firm
- Clinical Innovations, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-09
- Firm location
- Murray, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Due to complaints of device breakage at the traction force gauge to handle joint.
Data sourced from openFDA. This site is unofficial and independent of the FDA.