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Recall

Class II — Sam Medical Products

Recalling firmSAM Medical Products
Registered facilitySAM MEDICAL PRODUCTS (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonSAM Junctional Tourniquet (SJT) Auxiliary strap, model SJT 102 and SJT 112, is recalled because the snap hook on auxiliary strap broke during training demonstration.
ProductSAM 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.
Quantitytotal 3633 units (3342 units in US and 291 units Outside US)
DistributionWorldwide 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.
Initiated2014-08-14
Classified2014-10-24
Terminated2015-07-21
Recall numberZ-0133-2015
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Sam Medical Products (Z-0133-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69395/

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