{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "130412", "product_res_number": "Z-0133-2015", "event_date_initiated": "2014-08-14", "event_date_posted": "2014-12-16", "recall_status": "Terminated", "event_date_terminated": "2015-07-21", "res_event_number": "69395", "product_code": "DXC", "k_numbers": [ "K123694", "K131561" ], "product_description": "SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112.\n\nThe SJT models specific intended uses are to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture.", "code_info": "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.", "firm_fei_number": "3023316", "recalling_firm": "Sam Medical Products", "address_1": "27350 SW 95th Ave Ste 3038 27350 SW 95th Ave", "address_2": "Ste 3038", "city": "Wilsonville", "state": "OR", "postal_code": "97070-7709", "additional_info_contact": "Customer Service\n800-818-4726", "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_description": "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. \nSAM Medical Products sent the \"URGENT: MEDICAL DEVICE RECALL\" letter, dated September 10, 2014, to their consignees.\nThe 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.\n\nSAM 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.\nDistributors 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\ninstructions on the FAX Back document).\n\nCustomers 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.\n\n\nCustomer can contact SAM Medical Customer Service at:\n\n-Email customerservice@sammedical.com\n-Phone (503) 639-5474, Monday through Friday, 7:30-4:30, Pacific Time\n-Toll free l-800-818-4726\n-Website: vww.sammedical.com", "product_quantity": "total 3633 units (3342 units in US and 291 units Outside US)", "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.", "openfda": { "k_number": [ "K123194", "K022754", "K132175", "K071225", "K925809", "K982365", "K123041", "K964547", "K832554", "K791098", "K162988", "K011208", "K921399", "K882879", "K131411", "K011078", "K963503", "K142359", "K991589", "K080169", "K173563", "K813062", "K963716", "K040730", "K964663", 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}