FDAFDA · Food and drugs·Recall number Z-2226-2018
Part #: SAM XT-M, Model: Tactical Black or Military
Published June 20, 2018 · Recall initiated: May 2, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- The Seaberg Company Inc
- Distributor
- 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
- Lot
- Lot #: XT1711, XT1712, XT1713, XT1715, XT1719, XT1720, XT1721, XT1722, XT1723, XT1724, XT1725, XT1726, XT1727, XT1728, XT1729, XT1730, XT1731, XT1732, XT1734, XT1737, XT1738, XT1740, XT1742, XT1743, XT1744, XT1745, XT1746, XT1747, XT1748, XT1749, XT1750, XT1751, XT1752, XT1801, XT1803, XT1804, XT1805, XT1806, XT1807, XT1808, XT1809, XT1810, XT1811
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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