FDAClass IINovember 5, 2014

SAM Junctional Tourniquet recall

SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses are to control difficult bleeds in the…

Why was SAM Junctional Tourniquet recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

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…
Recalling firm
Sam Medical Products
Quantity
total 3633 units (3342 units in US and 291 units Outside US)
Distribution
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.
Recall date
November 5, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls