FDA Notice SAM Junctional Tourniquet

SAM Junctional Tourniquet Accessory (Axilla) Strap/SAM Medical Products: Recall – Potential Clip Failure

AUDIENCE: Emergency Medicine, Critical Care Medicine, Risk Manager

ISSUE: SAM Medical Products notified customers 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 SAM Junctional Tourniquet (SJT). The company 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.

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.

BACKGROUND: The SAM Junctional Tourniquet has received 510K clearance for controlling inguinal hemorrhage, axilla hemorrhage, and pelvic fracture stabilization.

RECOMMENDATION: SAM Medical Products has notified customers of the voluntary recall by letter and is arranging with its customers to rapidly replace the current axilla straps with an updated version.

For more information or questions related to this notification, please contact SAM Medical Products Customer Service at 1-800-818-4726 or (503) 639-5474 or email at customerservice@sammedical.com.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the recall notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm417985.htm

0 replies

Leave a Reply

Want to join the discussion?
Feel free to contribute!

Leave a Reply

Your email address will not be published. Required fields are marked *