Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Deli...
Reason for Recall / Hazard
Due to complaints of device breakage at the traction force gauge to handle joint.
Product Description & Identification
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.
Affected Products
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Murray |
| State | UT |
| Event id | 98597 |
| Address 1 | 747 W 4170 S |
| Code info | Model/Catalog Number: VAC-6000MT UDI: 00814247020642 Lot Code: 251327 251333 251328 251330 251370 251388 251545 251546 251582 251583 251680 251681 |
| Postal code | 84123-1364 |
| Report date | 20260506 |
| Product type | Devices |
| Product quantity | 49,175 devices |
| Reason for recall | Due to complaints of device breakage at the traction force gauge to handle joint. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260309 |
| Initial firm notification | Letter |
| Center classification date | 20260424 |
Overview
- Recalling FirmClinical Innovations, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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.