The United States Food and Drug Administration (FDA) posted a medical device safety alert concerning the Accessory (Axilla) strap for the SAM Junctional Tourniquet (SJT), manufactured by SAM Medical Products.
According to the FDA, the manufacturer notified affected users of a voluntary recall to address a potential issue with a clip used to secure the accessory strap used for the Axilla application of the SJT.
If this piece were to fail in actual use the operator may face a potential delay in using the SJT in the Axilla area. All other indications of the SJT (inguinal hemorrhage and pelvic fracture) are not impacted by this issue. The manufacturer is replacing the current axilla straps with an updated version.
The manufacturer has not received any reports of patient injuries to date related to this issue nor has it been reported to fail during actual patient use.
For details, please refer to the following FDA websites:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm417985.htm
http://www.fda.gov/Safety/Recalls/ucm417940.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 09 October 2014