Class I - Dangerous
The set screw is not able to advance or reverse from the original position in the nail.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
The set screw is not able to advance or reverse from the original position in the nail.
Class I - Dangerous
The set screw is not able to advance or reverse from the original position in the nail.
Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.
SPS Sterilization
Class I - Dangerous
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
Class I - Dangerous
The set screw is not able to advance or reverse from the original position in the nail.
Class I - Dangerous
The set screw is not able to advance or reverse from the original position in the nail.
Class I - Dangerous
The set screw is not able to advance or reverse from the original position in the nail.
Class I - Dangerous
The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was observed around a triglyceride concentration 600mg/dL, however the current triglyceride interference claim states interference should not occur below 800mg/dL of triglyceride.
Class I - Dangerous
The set screw is not able to advance or reverse from the original position in the nail.
Class I - Dangerous
The set screw is not able to advance or reverse from the original position in the nail.
Class I - Dangerous
The set screw is not able to advance or reverse from the original position in the nail.
Class I - Dangerous
The set screw is not able to advance or reverse from the original position in the nail.
Class I - Dangerous
The set screw is not able to advance or reverse from the original position in the nail.
Class I - Dangerous
The set screw is not able to advance or reverse from the original position in the nail.
Class I - Dangerous
The set screw is not able to advance or reverse from the original position in the nail.
Class I - Dangerous
The set screw is not able to advance or reverse from the original position in the nail.
Class I - Dangerous
The set screw is not able to advance or reverse from the original position in the nail.
A small number of devices in this lot may have a melted cap and a hole formed through the packaging. The risk is potentially the product will no longer be sterile for use and may cause harm to a patient.
Class I - Dangerous
The set screw is not able to advance or reverse from the original position in the nail.
Class I - Dangerous
The set screw is not able to advance or reverse from the original position in the nail.