Other Medical Devices

After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.

After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.

After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.

After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.

After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.

After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.

After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.

After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.

After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.

Possible nonconforming blades may result in a higher than specified cut force required to cut the suture.

After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.

After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.

Baxter r recalled this device due to the use of an incorrect plastic formulation in the manufacture of the blue luer component of the FLOSEAL malleable tips.

The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death.

After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.

The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death.

Siemens Healthcare Diagnostics has observed a negative bias for the carbohydrate-deficient transferrin (CDT) measurement when using the affected N Latex CDT lots in comparison to the HPLC method. CDT results in absolute concentrations may be influenced by patients transferrin levels and, therefore, results are reported as ratio of CDT to total transferrin, called %CDT. As the transferrin determination with N Antiserum to Human Transferrin is not affected, the observed effect leads to calculated %CDT values that show a negative bias of approximately 15% compared to the HPLC method. This could result in a shift of weak positive patient samples into the reference range of 1.19  2.47 %CDT which was derived from a study population of healthy adults. There are no control or calibrator materials that would catch this bias.

On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the Aux O2 + Air function the switch could unexpectedly switch from the Aux O2 + Air position back to the circle position. These situations could lead to hypoxia.

The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death.

On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the Aux O2 + Air function the switch could unexpectedly switch from the Aux O2 + Air position back to the circle position. These situations could lead to hypoxia.