FDAFDA · Food and drugs·Recall number Z-2228-2018
Part #: SAM XT-C, Model: Hi-Viz Blue
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 #: XT1808, XT1809, XT1810
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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