Recall Z-0133-2015 ยท DXC Clamp, Vascular
Sam Medical Products
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.
| Date | Dec 16, 2014 (initiated Aug 14, 2014) |
| Status | Terminated |
| Reason | 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 | 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 |
| 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. |
| FDA record | Open on fda.gov |