Recalling Firm / Manufacturer

Bound Tree Medical Europe Ltd

Product

Bound Tree Economy Extremity Vacuum Splints

Description

Orthoses: splints

Code Information

SP041 Bound Tree Economy Extremity Vacuum Splint (Wrist)
SP042 Bound Tree Economy Extremity Vacuum Splint (Arm)
SP043 Bound Tree Economy Extremity Vacuum Splint (Leg)
SP040 Set of three disposable extremity vacuum splints

Reason of Recall

Please be advised that repeated testing of the above products may result in failure to achieve a vacuum. There has been one reported incidence of the valve detaching from the main body of a disposable economy extremity splint. Products SP040, SP041, SP042 and SP043 are disposable items and are intended for single use. Bound Tree Medical has revised the instructions for use to clarify the appropriate product testing procedure to use on the disposable economy vacuum splint range.

Date Recall Initiated

January 1, 2010

Action

Changes/updates have been made to instructions for use. Changes/updates have been made to labelling.

Contact

N\A

Source

MHRA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.