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Recall Observatory FDA recall evidence

Device 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.

Z-0133-2015

August 14, 2014

Class II

Product summary

Firm
Sam Medical Products
Event
Event 69395
Status
Terminated
Classification
Class II
Quantity
total 3633 units (3342 units in US and 291 units Outside US)
Official record key
device-enforcement:Z-0133-2015

Official wording

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.

Code information: SJT 112 Lot number (represented as date codes): 6/5/14; SJT 102 Lot numbers (represented as date codes): 3/29/2013, 5/15/2013, 6/11/2013, 7/16/2013, 8/27/2013, 9/3/2013, 9/10/2013, 11/4/2013, 12/9/2013, 12/11/2013, 1/10/2014, 1/30/2014, 2/25/2014, 3/4/2014, 3/5/2014, 3/19/2014, 3/21/2014, 3/24/2014, 3/31/2014, 4/1/2014, 4/2/2014, 4/4/2014, 4/7/2014, 4/9/2014, 4/11/2014, 4/22/2014, 4/28/2014, 4/29/2014, 5/5/2014, and 6/12/2014.

Distribution pattern: Worldwide Distribution: US (nationwide) in states of Ohio, Oregon, New Mexico, North Carolina, Texas and to the following countries: Australia, Canada, Hong Kong, Iceland, Japan, Lebanon, Singapore, Thailand, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.