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Recall Observatory FDA recall evidence

Device product

Part #: SAM XT-C, Model: Hi-Viz Blue

Z-2228-2018

May 02, 2018

Class II

Product summary

Firm
The Seaberg Company Inc
Event
Event 80140
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2228-2018

Official wording

Reason: 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.

Code information: Lot #: XT1808, XT1809, XT1810

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.