FDAClass IIJune 20, 2018

Part #: SAM Xt-c recall

Part #: SAM XT-C, Model: Hi-Viz Orange or Civilian

Why was Part #: SAM Xt-c recalled?

Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to stop arterial blood flow. There is a remote chance that a serious injury and/or death could occur as a result of the failure of the device.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: XT1711, XT1712, XT1715, XT1716, XT1717, XT1719, XT1722, XT1723, XT1724, XT1726, XT1730, XT1731, XT1732, XT1734, XT1735, XT1736, XT1737, XT1738, XT1741, XT1744, XT1745, XT1748, XT1750, XT1751, XT1803, XT1804, XT1806, XT1807, XT1808

Product
Part #: SAM XT-C, Model: Hi-Viz Orange or Civilian
Recalling firm
The Seaberg Company Inc
Quantity
N/A
Distribution
USA: CA, MD, OH, FL, ID, CO, CT, OR, AZ, IL, ME, MO, NY, SC, MI, AR, MT, CT, WA, TX, KY, NC, NJ, PA OUS: Australia, Canada, China, Columbia, Costa Rica, Europe (EU), Hong Kong, Iceland, India, Iraq, Israel, Japan, Kenya, Korea, Lebanon, Malaysia, Russia, Saudi Arabia, Singapore, South Africa, Thailand, UAE
Recall date
June 20, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls