Clinical Innovations, LLC: Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Descrip
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Clinical Innovations, LLC
- 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 / hazard
- Due to complaints of device breakage at the traction force gauge to handle joint.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide - U.S. Nationwide distribution including in the states of AK, AR, AZ, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MI, MN, MS, NC, NE, NH, NV, NY, OH, PR, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Canada, China, Japan, Czech Republic, and Singapore.
- Recall initiated
- 2026-03-09
- Code info
- Model/Catalog Number: VAC-6000MT UDI: 00814247020642 Lot Code: 251327 251333 251328 251330 251370 251388 251545 251546 251582 251583 251680 251681
- Product quantity
- 49,175 devices
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Murray
- State
- UT
- Country
- United States
- Event id
- 98597
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