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.

Due to complaints of device breakage at the traction force gauge to handle joint.

On 03/10/2026, the firm emailed an "URGENT MEDICAL DEVICE RECALL" Letter to customers informing them that there is a potential of failure on the handle breaking at the Traction Force Indicator handle joint on the Kiwi Complete Vacuum Delivery System (VAC-6000MT) when angular force is applied to the handle. Customers are instructed to: 1. Identify and quarantine all unused inventory of the affected product. 2. Discontinue distribution of the affected product. 3. Return all unused, affected product to Clinical Innovations (Laborie), regardless of the labeled expiration date. 4. Complete and return the attached Recall Acknowledgement and Receipt Form within 15 business days, even if no inventory remains. Return the forms via email to [email protected]. 5. If customers have product to return, a company representative will contact them once Clinical Innovations has receive their Recall Acknowledgement and Receipt Form to issue them an RMA per company policy and arrange for a product return. For questions, call Clinical Innovations (Laborie), at 1-(888)- 268-6222 M-F 8:00 AM- 5:00 PM MT or + (33) 383 22 20 76 M-F 8:00 AM - 5 PM GMT +2 or their Clinical Innovation's (Laborie) service representative.