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Terminated

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.

FDA Recall Z-0133-2015 · Posted 2014-12-16

Recalling FirmSam Medical Products
Recall StatusTerminated
Product CodeDXC
Date Initiated2014-08-14
Date Terminated2015-07-21
Product Quantitytotal 3633 units (3342 units in US and 291 units Outside US)

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.

Firm 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

Root Cause

Component design/selection

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K131561SAM JUNCTIONAL TOURNIQUETSam Medical Products · 2013-07-24K123694SAM JUNCTIONAL TOURNIQUETSam Medical Products · 2013-03-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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