Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device and device performance during use.
North American Rescue
The device includes the incorrect Instructions for Use.
Lack of sterility assurance of the 30-0171
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.