Field Safety Notice Performance Health Days Adjustable Crutches GTV85193 and GTV85182 (ICN 2918)

Alert:

• Performance Health International has issued a Field Safety Notice having identified a limited number of Days adjustable standard crutches supplied since September 2024 that may contain defective handles due to a manufacturing error.
• Performance Health advise they believe the likelihood of the handle becoming fully detached is minimal and have not received any reports of this happening.
• As a precautionary measure the company are requesting the affected lot numbers are removed from use and destroyed.

Products Affected:

• Two of the products affected are available on the eDirect route from NHS Supply Chain:

• Please note only the lot numbers in the Field Safety Notice, and listed above, are affected.

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 the affected lot numbers.
• Complete the Reply Form “Confirmation of Destruction of Crutches in relation to Field Safety Corrective Action Notice dated APR 2025” and return to: UKREG@performancehealth.com before 30 May 2025 latest. On receipt Performance Health will arrange to send you replacements.
• To enable us to help if needed please also Contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products destroyed and notified to Performance Health, including NPC, lot numbers and quantity.

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