SAM XT Extremity Tourniquet Tactical Black (PN SAM XT-M), SAM XT Extremity Tourniquet Hi-Viz Orange (PN SAM XT-C) and SAM XT Extremity Tourniquet Hi-Viz Blue (PN SAM XT-B) (2018-05-01)
- Starting date:
- May 1, 2018
- Posting date:
- May 18, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-66808
Affected products
A. SAM XT Extremity Tourniquet Tactical Black (PN SAM XT-M)
B. SAM XT Extremity Tourniquet Hi-Viz Orange (PN SAM XT-C)
C. SAM XT Extremity Tourniquet Hi-Viz Blue (PN SAM XT-B)
Reason
Sam medical products initiated the recall after internal testing indicated a possible failure of 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.
Affected products
A. SAM XT Extremity Tourniquet Tactical Black (PN SAM XT-M)
Lot or serial number
XT1711 to XT1811
Model or catalog number
SAM XT-M
Companies
- Manufacturer
-
The Seaberg Company, Inc DBA SAM Medical Products
27350 South-West 95th Avenue. Suite 3038
Wilsonville
97070
Oregon
UNITED STATES
B. SAM XT Extremity Tourniquet Hi-Viz Orange (PN SAM XT-C)
Lot or serial number
XT1711 to XT1811
Model or catalog number
SAM XT-C
Companies
- Manufacturer
-
The Seaberg Company, Inc DBA SAM Medical Products
27350 South-West 95th Avenue. Suite 3038
Wilsonville
97070
Oregon
UNITED STATES
C. SAM XT Extremity Tourniquet Hi-Viz Blue (PN SAM XT-B)
Lot or serial number
XT1808 to XT1811
Model or catalog number
SAM XT-B
Companies
- Manufacturer
-
The Seaberg Company, Inc DBA SAM Medical Products
27350 South-West 95th Avenue. Suite 3038
Wilsonville
97070
Oregon
UNITED STATES