Field Safety Notice Laborie Medical Technologies UK Ltd Kiwi Complete Vacuum Delivery System FFK019 (ICN 3297)

NHSSC: 122

Alert:

• Laborie Medical Technologies UK Ltd has issued a Field Safety Notice following customer reports of failure of handle break at the Traction Force Indicator handle joint.
• The field action is being conducted due to a manufacturing issue which can compromise the integrity of the bond between the Traction Force Indicator (TFI) and handle joint when certain use techniques are utilized.
• Breakage of the device results in complete loss of vacuum which can lead to a delay in the procedure while another mode of delivery is employed or the possible conversion to caesarean section delivery. Delaying a procedure may pose an increased risk of harm when the indication for vacuum assisted delivery is foetal distress. In cases of use in caesarean sections, it is also theoretically possible that fragments could fall into the patient.

Products Affected:

• One product is affected.
• The affected product was available via NHS Supply Chain.

• Please note only the lot numbers quoted in the Field Safety Notice are affected.
• NHS Supply Chain stock has been checked and all the affected products quarantined.
• This product is currently suspended and unavailable to order.
• See our Useful Links to view ICN 3294 for more information on product availability.
• Potential indirect alternative products are available to order through our online catalogue:
  • FFK000 – Vacuum assisted device, without traction force indicator (the amount of force applied is not measured)
  • FFK224 -Vacuum assisted device, Obstetric Cup with traction force indicator.
• See our Downloads ▼ section to access the product listing for further information on the affected product and potential alternatives.
• Where potential alternatives are identified, Customers are advised to consult your own clinical experts to ensure suitability for your organisation’s use of these products.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine all affected lot numbers.
• Contact your local NHS Supply Chain Customer Service Advisor with full details of affected products for return, reason code seven Supplier recall. All products must be returned no later than 10 April 2026.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Acute team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.