⬅ Back to All Recalls

Kiwi® Vacuum Assisted Delivery System Recall Due to The device may break at t...

# Major Recall Alert: Kiwi® Vacuum Assisted Delivery System Recalled Due to Safety Concerns

The Kiwi® Vacuum Assisted Delivery System is undergoing a recall due to a potentially serious safety issue. The device is prone to breaking at the Traction Force Indicator (TFI) joint when traction is applied at approximately a 45-degree angle, posing risks during use. Health professionals, expectant parents, and caregivers must stay informed about this recall to mitigate potential health and safety hazards.

## Why This Recall is Important

Medical devices play a critical role during labor and delivery, and their reliability can affect both maternal and neonatal outcomes. The Kiwi® Vacuum Assisted Delivery System is designed to assist in childbirth by providing controlled vacuum suction for delivery assistance. However, this recall highlights a significant flaw: the Traction Force Indicator (TFI) joint may fail under specific stress.

The potential for the TFI joint to break when traction is applied at a 45-degree angle could impact the delivery process and endanger the patient. Ensuring the safety of all medical devices is paramount, making this recall an urgent matter for healthcare facilities to address.

## Details of the Recall

Here’s a summary of the key details regarding the Kiwi® Vacuum Assisted Delivery System recall:

- **Category:** Medical Device
- **Brand:** Kiwi® Vacuum Assisted Delivery System
- **Product Name:** Kiwi® Vacuum Assisted Delivery System
- **Recall Reason:** The device may break at the Traction Force Indicator (TFI) joint during use when traction is applied at approximately a 45-degree angle.
- **Safety Concern:** Breakage at the TFI joint can compromise the efficacy of the device during assisted delivery, potentially leading to adverse outcomes.
- **Date Announced:** October 2023
- **Source to Learn More:** Refer to the official government recall notice [here](https://recalls-rappels.canada.ca/en/alert-recall/kiwir-vacuum-assisted-delivery-system).

Ensuring timely action is vital. Venues using this device are urged to review their inventory and follow the necessary precautions to protect patients and healthcare professionals.

## What You Should Do

If you or your healthcare facility uses the Kiwi® Vacuum Assisted Delivery System, here’s what you need to do:

- **Stop Using the Device:** Immediately discontinue use of the Kiwi® Vacuum Assisted Delivery System if it is in your inventory.
- **Contact Manufacturer:** Reach out to the manufacturer or supplier to report the issue and arrange for device returns or replacements.
- **Report Any Incidents:** Healthcare professionals should report any related device malfunctions or patient safety concerns to the appropriate regulatory authority.
- **Inform Your Team:** Ensure all staff members are notified of the recall to prevent unintentional usage of the recalled product.
- **Stay Updated:** Regularly check for updates or guidance from the official recall authorities via the [official recall notice](https://recalls-rappels.canada.ca/en/alert-recall/kiwir-vacuum-assisted-delivery-system).

Patients can inquire with their healthcare providers to confirm that this product is not being used in their care.

## Stay Safe – Get Instant Recall Alerts

For timely alerts on recalls like this one, consider downloading a recall notification app. Staying informed allows you to take swift action to protect yourself or your loved ones from potentially unsafe products.

Act now to safeguard your health and safety! Keep a proactive approach by downloading the latest recall alert app today. Knowledge is your best tool in protecting yourself and others.

---

This recall underscores the importance of ensuring that all medical devices meet the highest safety standards. Always prioritize your Well-being and stay informed about important product recalls. Review the official recall notice at [recalls-rappels.canada.ca](https://recalls-rappels.canada.ca/en/alert-recall/kiwir-vacuum-assisted-delivery-system).

⬅ Back to All Recalls