SAM Junctional Tourniquet, 2 Target Compression Devices (1 with extender), Hand Pump, Auxiliary Strap (2014-09-18)

Starting date:

September 18, 2014

Posting date:

October 10, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-41761

• Reason
• Affected products

Recalled Products

SAM Junctional  Tourniquet, 2 Target Compression Devices (1 with extender), Hand Pump, Auxiliary Strap 

Reason

SAM medical is voluntarily recalling the Sam Junctional Tourniquet (SIT) auxiliary (accessory) strap, which is intended for use in the control of difficult bleeds in the axilla area. Only the auxiliary strap is affected. The remaining components of the SIT are not impacted by this recall and function as intended. It was determined through customer feedback and subsequent internal testing that the rear retaining clip failed in a very small number of devices during training demonstrations. No report of patient injury nor has the device been reported to fail during actual patient use.

Affected products