SAM Medical Products Recalls Junctional Tourniquet Auxiliary Straps
Sam Medical Products is recalling SJT 102 and 112 auxiliary straps because the snap hook broke during a training demonstration.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device intended to control life-threatening bleeding where a mechanical failure (broken snap hook) occurred, representing a risk of harm even though no injuries are reported.
Plain-English summary
Sam Medical Products is voluntarily recalling the SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. These devices are specifically intended to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture.
The recall was initiated because the snap hook on the auxiliary strap broke during a training demonstration. The affected units were distributed worldwide, including nationwide in the United States and in specific states such as Ohio, Oregon, New Mexico, North Carolina, and Texas. International distribution included Australia, Canada, Hong Kong, Iceland, Japan, Lebanon, Singapore, Thailand, and the United Kingdom.
A total of 3,633 units are involved in this recall, with 3,342 units in the US and 291 units outside the US. Specific lot numbers, represented as date codes, are listed for both the SJT 112 and SJT 102 models. Users should stop using these devices and contact Sam Medical Products for further instructions.
The recalled product
- 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.
- Manufacturer
- Sam Medical Products
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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