Z-2228-2018Class II

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

Name: Z-2228-2018 Part #: SAM XT-C, Model: Hi-Viz Blue
Creator: The Seaberg Company Inc
Published: 2018-05-02
License: https://open.fda.gov/license/

Sam Medical Products / initiated 2018-05-02 / Terminated / root cause: manufacturing process

FDA source

The Seaberg Company Inc began a recall of Part #: SAM XT-C, Model: Hi-Viz Blue on 2018-05-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2228-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-02
Posted: 2018-06-14
Terminated: 2020-07-01
Recalling firm: Sam Medical Products
Product: Part #: SAM XT-C, Model: Hi-Viz Blue
Product code: GAX Tourniquet, Nonpneumatic
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.
Root cause tag: manufacturing process
FDA 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.
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
Product codes and lots: Lot #: XT1808, XT1809, XT1810

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2228-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2226-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2227-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2228-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14

Product code GAX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)