Seaberg SAM XT-C Tourniquet Recalled for Potential Buckle Stitch Failure
The Seaberg Company is recalling SAM XT-C tourniquets because internal testing showed stitches securing the buckle could 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 'remote chance that a serious injury and/or death could occur' exists due to the device failure, which aligns with the rubric criteria for a Severe (4) rating involving significant injury or death risk.
Plain-English summary
The Seaberg Company Inc is recalling SAM XT-C tourniquets, Model Hi-Viz Blue, due to a potential defect identified during internal testing. The recall affects units with lot numbers XT1808, XT1809, and XT1810.
Internal testing indicated that the stitches securing the buckle to the nylon belt could fail. This failure poses a potential risk when the device is used on a human patient to stop arterial blood flow, as there is a remote chance that a serious injury and/or death could occur as a result of the device failure.
The affected products were distributed in the United States (including CA, MD, OH, FL, ID, CO, CT, OR, AZ, IL, ME, MO, NY, SC, MI, AR, MT, WA, TX, KY, NC, NJ, and PA) and internationally (including Australia, Canada, China, Columbia, Costa Rica, Europe, Hong Kong, Iceland, India, Iraq, Israel, Japan, Kenya, Korea, Lebanon, Malaysia, Russia, Saudi Arabia, Singapore, South Africa, Thailand, and UAE). Consumers and healthcare providers should stop using the affected tourniquets and contact The Seaberg Company Inc for further instructions.
The recalled product
- Product
- Part #: SAM XT-C, Model: Hi-Viz Blue
- Manufacturer
- The Seaberg Company Inc
- Category
- Medical Device — Tourniquet
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 (3)
- Lot #: XT1808
- XT1809
- XT1810
Distribution
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 →Related recalls
Same manufacturer · The Seaberg Company Inc
See all →- SevereSeaberg SAM XT-C Tourniquet Recall Due to Potential Buckle Failure
FDA (Devices) · 2018-06-20
- SevereSeaberg SAM XT-M Tourniquet Recalled for Potential Buckle Failure
FDA (Devices) · 2018-06-20
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