SAM XT

Voluntary Recall Program

Xt Family

SAM Medical has determined that, in rare cases, the stitches of the SAM XT Extremity Tourniquet (SAM XT) securing the buckle to the nylon belt may fail, posing a potential risk when used on a human patient to stop arterial blood flow. To date, there have been no reports of adverse health consequences received. This product has been sold worldwide since March 2017 by SAM Medical, and other distributors.

Customer safety is always SAM Medical's top priority, and we have voluntarily decided to recall this product. If you have an unused or unopened SAM XT, please follow the process below to send back through your distribution channel. In exchange, we will provide you with a new SAM XT. 

This program only applies to the SAM XT Extremity Tourniquet which is shown to the right. The SAM XT comes in three colors: Tactical Black, Hi-Viz Orange and Hi-Viz Blue, which are also shown on this web page. 

IDENTIFYING YOUR SAM XT


IDENTIFY BY THE IFU 
Compare your tourniquet to the images in Figure A.1. An affected tourniquet will not have the “Box X Stitch” icon on the upper right of the folded Instructions For Use (IFU) insert. Tourniquets not affected will display the “Box X Stitch” icon on the upper right of the folded IFU.fig-a1_ifu.jpg#asset:1276


IDENTIFY BY STITCH PATTERN
Compare your tourniquet to the images in Figure A.2. An affected tourniquet will have a multi-pass straight lockstitch. Tourniquets not affected will have a “Box X” stitch (stitching is highlighted in red for display purposes only).fig-a2_stitch.jpg#asset:1277


IDENTIFY BY LOT NUMBER 
If your tourniquet has been removed from the packaging please compare to the images in Figure A.3. You may find the lot number etched on the front of the Buckle or on the printed shipping label on the original shipping case. An affected tourniquet has a lot number of XT1711 - XT1811. Tourniquets not affected will have lot numbers from XT1812 and onward.fig-a3_lot.jpg#asset:1278

EXCHANGE PROCESS


SAM Medical is notifying all distributors and direct sales customers to arrange for a return of all recalled product. Distributors and customers have been asked to return all affected product back through their distribution channel. To participate in this recall, please take the following actions:

  1. Immediately examine your inventory and quarantine product subject to recall.
  2. Immediately discontinue use and distribution of the identified lot number.
  3. Return product through your distribution channel.
  4. NOTE: A Returned Material Authorization (RMA) must be obtained to send back unused (case boxes, individual wrapped or unwrapped and never used) products.
  5. A pre-paid return label will be provided to you for the product return; return shipment is free of charge. For the RMA, contact your distributor’s Customer Service.
  6. Please provide the total quantities of SAM XTs by color, as well as the shipping container's weight and dimensions used for the exchange in order to generate the RMA return shipping documentation. Contact SAM Medical via email at xtrecall@sammedical.com.
  7. If you have further distributed this product, please identify those customers and notify them at once of this product recall.


This recall is being carried out to the user level.

FAQs

The company initiated this voluntary recall after internal testing indicated a possible failure of the stitches securing the buckle to the nylon belt.

SAM Medical is notifying all distributors and direct sales customers. SAM Medical is also issuing a global press release in an effort to notify all end users of the SAM XT.

  1. Immediately examine your inventory and quarantine product subject to recall.
  2. Immediately discontinue use and distribution of the identified lot number.
  3. Return product through your distribution channel.
  4. NOTE: A Returned Material Authorization (RMA) must be obtained to send back unused (case boxes, individual wrapped or unwrapped and never used) products.
  5. A pre-printed, pre-paid return label will be provided to you for the product return; return shipment is free of charge. For the RMA, contact your distributor’s Customer Service.
  6. You will be asked for the product weight and dimensions which is required for generation of the RMA return shipping documentation. Contact SAM Medical via email at xtrecall@sammedical.com.
  7. If you have further distributed this product, please identify those customers and notify them at once of this product recall.

This voluntary recall involves all SAM XTs manufactured with the multi-pass straight lockstitch and distributed from March 2017 through April 2018 containing lot numbers 1711 through 1811. The most certain way to determine if an SAM XT is affected is to examine the stitching. The stitch method has been changed from a multi-pass straight lockstitch to a "Box X" stitch. A "Box X" stitch is a rectangular or box stitch pattern with stitching in the shape of an ‘X’ inside the rectangle. Please see "Identifying Your SAM XT" in the sections above. 

The stitch protocol has been changed from a multi-pass straight lockstitch to a "Box X" stitch. A "Box X" stitch is a rectangular or box stitch pattern with stitching in the shape of an ‘X’ inside the rectangle. Please see "Identifying Your SAM XT" in the sections above. 

All SAM XTs are now being made with a "Box X" stitch which produces an inherently stronger stitch pattern. In addition, the company has initiated more extensive simulated-use testing to ensure the stitching is consistently reliable.

All SAM XTs are now being made with a "Box X" stitch which produces an inherently stronger stitch pattern. This stitching pattern replaces the previous multi-pass straight lockstitch.

A "Box X" stitch is a rectangular box stitch pattern with additional stitching in the shape of an ‘X’ inside the rectangle. See "Identifying Your SAM XT" in the sections above. 

A multi-pass straight lockstitch is a stitch pattern in which four passes of a sewing machine have been done back and forth in a straight line over an area of the SAM XT strap. See "Identifying Your SAM XT" in the sections above. 

The scope of the recall only applies to a SAM XT that is still in the unopened protective plastic wrap, or a SAM XT that is no longer in the protective plastic wrap, and has not been applied to the arm or leg of a human or a training manikin, or applied to any other object.

No. Only unused SAM XTs qualify for return and replacement.

To date, SAM Medical has not received any reports of adverse health consequences as a result of application of affected SAM XTs.

No. The SAM XTs retain the same NSN as previously issued.

Previously used SAM XTs are outside the scope of the recall.

Yes, you can find an updated press kit for the SAM XT containing new product images here: https://www.dropbox.com/sh/4la...

You will receive instructions and a letter to send to the end user explaining the return and replacement process.

Contact your distributor. Ask for return and replacement information for the SAM XT. The distributor will provide details on which XTs are affected, and how and where to return it at no charge to you.

Yes, but only if you purchased your XT directly from SAM Medical. If you purchased your XT from a distributor, please contact the distributor from which you purchased the product. If you didn’t purchase your XT from a distributor or directly from SAM Medical, please contact SAM Medical at xtrecall@sammedical.com.

Yes. If you purchased an affected SAM XT from a distributor, please contact that distributor for return and replacement information. If you purchased an affected SAM XT from outside of a distribution channel, please contact SAM Medical at xtrecall@sammedical.com for return and replacement information.

Unless required by local regulations to provide a refund, SAM XTs returned will be replaced with a newly manufactured SAM XT.

If you have received a sample and it's unopened or opened and unused, it should be returned through your distribution channel. Samples will be issued as required moving forward. 

Contact your reseller on Amazon.


  1. SAM Medical will assume all costs of returning and replacing the XTs that are affected by this recall.
  2. If you are a SAM Medical Distributor, your return and replacement costs will be paid or reimbursed by SAM Medical through the normal course of business.
  3. If you purchased your XT from a SAM Medical distributor, contact that distributor to arrange for return shipping to be prepaid through that distributor.

If you purchased an affected XT from outside a distribution channel, please contact SAM Medical at xtrecall@sammedical.com to arrange for prepaid return shipping.

  1. SAM Medical will assume all costs of returning and replacing the XTs that are affected by this recall.
  2. If you are a SAM Medical Distributor, your return and replacement costs will be paid or reimbursed by SAM Medical through the normal course of business.
  3. If you purchased your XT from a SAM Medical distributor, contact that distributor to arrange for return shipping to be prepaid through that distributor.

If you purchased an affected XT from outside a distribution channel, please contact SAM Medical at xtrecall@sammedical.com to arrange for prepaid return shipping.

No lot code information is required for the return. 

Please contact your SAM Medical Sales Representative or Distributor for replacement information.

Please contact your SAM Medical Sales Representative or Distributor for replacement information.

Yes, SAM Medical will ship new product during the recall period.

No. 

SAM Medical and its distributors will use all efforts required by the US Food and Drug Administration, to have all affected SAM XTs returned. Not all SAM XTs will be returned, as some will have been used and disposed, or some will not qualify for the recall.

You will receive a new SAM XT.