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U.S. Department of Health and Human Services

Class 2 Device Recall SAM Junctional Tourniquet (SJT) Auxiliary

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  Class 2 Device Recall SAM Junctional Tourniquet (SJT) Auxiliary see related information
Date Initiated by Firm August 14, 2014
Date Posted December 16, 2014
Recall Status1 Terminated 3 on July 21, 2015
Recall Number Z-0133-2015
Recall Event ID 69395
510(K)Number K123694  K131561  
Product Classification Clamp, vascular - Product Code DXC
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.
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.   
Recalling Firm/
Manufacturer		 Sam Medical Products
27350 SW 95th Ave Ste 3038
Wilsonville OR 97070-7709
For Additional Information Contact Customer Service
800-818-4726
Manufacturer 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.
FDA Determined
Cause 2		 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 customerservice@sammedical.com -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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DXC and Original Applicant = SAM MEDICAL PRODUCTS
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