Field Safety Notice issued for Reliance Medical TraumaFix pelvic splints

Last Updated on 12/10/2026 by Sarah Sarsby

BHTA member Reliance Medical is recalling certain batches of its TraumaFix Professional and Tactical Pelvic Splints because the hook and loop strap has been assembled incorrectly.

The urgent Field Safety Notice, dated 30 September 2026 and published on the MHRA website, also covers affected splints supplied within specified batches of TraumaFix FREC (First Response Emergency Care) 3 Kits and refills.

What has been identified?

The splints are intended for the emergency treatment of suspected pelvic fractures. The incorrectly assembled strap cannot be secured to the splint as intended, preventing full immobilisation of the pelvis.

Reliance Medical states that the fault affects every device in the listed batches.

What is the potential risk?

The fault may delay treatment while the user seeks a way to secure the strap. If no solution is identified, treatment will have reduced efficacy.

The notice describes three responses a user might attempt: twisting the strap, which may limit tightening; tucking it in, which risks loosening; or rethreading it, which restores effectiveness but is not immediately obvious and takes additional time. These are scenarios considered in the risk assessment; the required action is to return affected devices.

Ineffective tightening may fail to control internal haemorrhage. Reliance Medical considers the risk unacceptable.

The notice does not recommend patient follow-up or review of previous results, and states that communication of the FSN to patients or lay users is not required.

Which products are affected?

Users and distributors should check product references and lot numbers against the following details.

What actions are required from users and distributors?

Reliance Medical instructs recipients to identify and return affected devices. For affected FREC 3 Kits and refills, only the pelvic splint needs to be returned. The notice specifies a three-month timeframe for both user actions and the manufacturer’s recall.

A customer reply is required. The acknowledgement form in Appendix 1 requests confirmation of receipt, affected lot details, and quantities sold and held in stock. It also asks distributors to confirm that they have notified affected customers and will arrange collection for return to Reliance Medical.

Users and distributors with questions about the notice or return arrangements can contact Reliance Medical on 08456 448808 or at FSN@reliancemedical.co.uk.

Passing on the notice

The notice should be shared with those who need to be aware within affected organisations and any organisation to which potentially affected devices have been transferred. Recipients are asked to maintain awareness of the notice and resulting action for an appropriate period to support the corrective action’s effectiveness.

Device-related incidents should be reported to the manufacturer, distributor, or local representative, and to the national competent authority where appropriate.

Further information

Full product identification details, required actions, and the acknowledgement form are available in the Reliance Medical Field Safety Notice.