Agency classClass IIOur severity:Severe FDA (Devices)·Z-2227-2018·Announced 2018-06-20

Seaberg SAM XT-C Tourniquet Recall Due to Potential Buckle Failure

The Seaberg Company is recalling SAM XT-C tourniquets because internal testing showed stitches securing the buckle might fail, posing a risk of serious injury or death.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states that a serious injury and/or death could occur as a result of the device failure, which aligns with the rubric criteria for a Severe rating involving significant injury or death reports.

Plain-English summary

The Seaberg Company Inc is recalling SAM XT-C tourniquets, available in Hi-Viz Orange or Civilian models. The recall covers specific lot numbers including XT1711, XT1712, XT1715, XT1716, XT1717, XT1719, XT1722, XT1723, XT1724, XT1726, XT1730, XT1731, XT1732, XT1734, XT1735, XT1736, XT1737, XT1738, XT1741, XT1744, XT1745, XT1748, XT1750, XT1751, XT1803, XT1804, XT1806, XT1807, and XT1808.

The recall was initiated after internal testing indicated a possible failure of the stitches securing the buckle to the nylon belt. This defect poses a potential risk when the device is used on a human patient to stop arterial blood flow. The source text notes a remote chance that a serious injury and/or death could occur as a result of the device failure.

The affected units were distributed across numerous US states, including California, Maryland, Ohio, Florida, Idaho, Colorado, Connecticut, Oregon, Arizona, Illinois, Maine, Missouri, New York, South Carolina, Michigan, Arkansas, Montana, Washington, Texas, Kentucky, North Carolina, New Jersey, and Pennsylvania. International distribution included 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, and the UAE.

The recalled product

Product: Part #: SAM XT-C, Model: Hi-Viz Orange or Civilian
Manufacturer: The Seaberg Company Inc
Category: Medical Device — Tourniquet
Hazard: structural-failure
serious-injury
death

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Lot #: XT1711
XT1712
XT1715
XT1716
XT1717
XT1719
XT1722
XT1723
XT1724
XT1726
XT1730
XT1731
XT1732
XT1734
XT1735
XT1736
XT1737
XT1738
XT1741
XT1744

Distribution

Distributed in 23 states:

Part of a larger recall action

This product is one of 3 recalled by The Seaberg Company Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · The Seaberg Company Inc

See all →

Severe
Seaberg SAM XT-M Tourniquet Recalled for Potential Buckle Failure
FDA (Devices) · 2018-06-20
Severe
Seaberg SAM XT-C Tourniquet Recalled for Potential Buckle Stitch Failure
FDA (Devices) · 2018-06-20

Same hazard · structural failure