medical Class II Updated 2018-06-20

The Seaberg Company Inc recalls Part #: SAM XT-C, Model: Hi-Viz Orange or Civilian

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: CA, MD, OH, FL, ID, CO, CT, OR, AZ, IL, ME, MO, NY, SC, MI, AR, MT, WA, TX, KY, NC, NJ, PA

Lot/Code Info: 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

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