Z-0133-2015Class II

SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses...

Name: Z-0133-2015 SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses...
Creator: Sam Medical Products
Published: 2014-08-14
License: https://open.fda.gov/license/

Sam Medical Products / initiated 2014-08-14 / Terminated / root cause: design

FDA source

Sam Medical Products began a recall of 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... on 2014-08-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0133-2015
Classification: Class II
Status: Terminated
Initiated: 2014-08-14
Posted: 2014-12-16
Terminated: 2015-07-21
Recalling firm: Sam Medical Products
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.
Product code: DXC Clamp, Vascular
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: SAM Medical Products issued the press release on August 29, 2014 and the link is http://www.ireachcontent.com/news-releases/sam-medical-products-implements-voluntary-recall-of-its-accessory-axilla-strap-for-the-sam-junctional-tourniquet-273239381.html. SAM Medical Products sent the "URGENT: MEDICAL DEVICE RECALL" letter, dated September 10, 2014, to their consignees. The 5 additional lot numbers (7/1/14, 7/2/14, 8/4/14, 8/7/14, and 8/11/14) that were erroneously placed on the recall notification letter and they are NOT part of the recall. SAM Medical Distributors will need to notify their customers via this letter and the included FAX Back document of the actions being taken as well as ship the replacement straps to individual customers. Distributors will document and report to SAM Medical that all customers have been notified and replacement straps delivered to these customers. Distributors will notify SAM Medical that the replaced straps have been destroyed. This information will be documented on the included FAX Back document and then returned to SAM Medical (via FAX, e-mail, or mail, per instructions on the FAX Back document). Customers will receive one complete Auxiliary Accessory Strap at no charge with a reinforced metal clip as a replacement. Once received, the existing strap should be removed from the SJT and replaced with the new strap. Customers/End Users need to complete and return the FAX Back document to the distributor from whom the FAX Back was sent. Customer can contact SAM Medical Customer Service at: -Email [email protected] -Phone (503) 639-5474, Monday through Friday, 7:30-4:30, Pacific Time -Toll free l-800-818-4726 -Website: vww.sammedical.com
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0133-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0133-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-05	2014-10-24

Product code DXC

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)