Recall Z-2228-2018
The Seaberg Company Inc · initiated May 2, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Part #: SAM XT-C, Model: Hi-Viz Blue
Codes / lots: Lot #: XT1808, XT1809, XT1810
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.
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-2228-2018
- Initiated
- May 2, 2018
- Terminated
- July 1, 2020
- Product code
- GAX – Tourniquet, Nonpneumatic
- 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
- Recalling firm
- The Seaberg Company Inc, Wilsonville, OR
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2226-2018 Class II | Part #: SAM XT-M, Model: Tactical Black or MilitaryBased on internal testing, results indicated a possible failure of the stitches securing the buckle to the… | 05/02/2018Terminated |
| Z-2227-2018 Class II | Part #: SAM XT-C, Model: Hi-Viz Orange or CivilianBased on internal testing, results indicated a possible failure of the stitches securing the buckle to the… | 05/02/2018Terminated |