FDA Device recall Z-2228-2018
Part #: SAM XT-C, Model: Hi-Viz Blue
- FDA Device
- Class II
- terminated
- Published 2018-06-20
On 2018-06-20 the FDA classified a Class II recall of Part #: SAM XT-C, Model: Hi-Viz Blue by The Seaberg, citing 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 pat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2228-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-02 |
| Published | 2018-06-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | The Seaberg |
| Distribution | AR, AZ, CA, CO, CT, FL, ID, IL, KY, MD, ME, MI, MO, MT, NC, NJ, NY, OH, OR, PA, SC, TX, WA |
Product
Part #: SAM XT-C, Model: Hi-Viz Blue
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.
Identifiers
| code_info | Lot #: XT1808, XT1809, XT1810 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2228-2018%22
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