Home / Recalls / The Seaberg Company Inc / Z-2227-2018

Z-2227-2018 Class II Terminated

Recalled by The Seaberg Company Inc — Wilsonville, OR

Recall Details

Product Type: Devices
Report Date: June 20, 2018
Initiation Date: May 2, 2018
Termination Date: July 1, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

Product Description

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

Reason for Recall

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.

Distribution Pattern

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

Code Information

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