FDA Medical Device Recalls (openFDA)
The Seaberg Company Inc: Part #: SAM XT-C, Model: Hi-Viz Blue
- Recall number
- Z-2228-2018
- Recalling firm
- The Seaberg Company Inc
- Product
- Part #: SAM XT-C, Model: Hi-Viz Blue
- Status
- Terminated
- Initiated
- 2018-05-02
- Posted
- not on file
- Terminated
- 2020-07-01
- 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.
- Root cause
- Employee error
- Action
- On 05/02/2018, the firm posted a press release notifying customers of a recall of all unused SAM XT Extremity Tourniquets (SAM XT) due to a possible failure of the stitches securing the buckle to the nylon belt that could pose a potential risk when used on a human patient to stop arterial blood flow. On 05/03/2018, recall notification forms were mailed to customers via overnight mail service.
- Quantity
- not on file
- Distribution
- 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, serial or model codes
- Lot #: XT1808, XT1809, XT1810
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GAX
- Firm FEI
- 3023316
- Firm city
- Wilsonville
- Firm state
- OR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28