Recall Z-0133-2015— Sam Medical Products

Name: FDA recall Z-0133-2015
Creator: U.S. Food and Drug Administration
Published: 2014-08-14

Class II · Terminated

Class II FDA medical device recall by Sam Medical Products, initiated 2014-08-14, terminated 2015-07-21. It names 2 FDA 510(k) clearances: K131561, K123694. Product: SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses are to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture.. Reason: SAM Junctional Tourniquet (SJT) Auxiliary strap, model SJT 102 and SJT 112, is recalled because the snap hook on auxiliary strap broke during training demonstration..

Recalling firm: Sam Medical Products
Classification: Class II
Status: Terminated
Initiated: 2014-08-14
Terminated: 2015-07-21
Firm location: Wilsonville, OR, United States

510(k) clearances named in this recall

2 on FDA's record

K131561 — SAM JUNCTIONAL TOURNIQUETSam Medical Products·cleared 2013-07-24
K123694 — SAM JUNCTIONAL TOURNIQUETSam Medical Products·cleared 2013-03-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses are to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture.

Reason for recall

SAM Junctional Tourniquet (SJT) Auxiliary strap, model SJT 102 and SJT 112, is recalled because the snap hook on auxiliary strap broke during training demonstration.

Data sourced from openFDA. This site is unofficial and independent of the FDA.