Medical Devices Recalls

Saline Flush Syringe compromised sterility due to holes in the packaging.

Saline Flush Syringe compromised sterility due to holes in the packaging.

Sterile catheter kit packaging compromised.

Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.

Due to programming errors in the Controller, an increase in the set motor parameters can be made by the end user beyond tested safe limits.

The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.

It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.

Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the use of a needle driver, there is a risk of needle stick to the surgeon tries to do it with fingers instead.

Intermittent communication due to inconsistent crimping of connectors onto cables.

The firm has become aware there is a potential problem with its DABRA catheters resulting in higher catheter calibration failure rate due to the product shelf life is currently less than the labeled shelf life.

The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.

Saline Flush Syringe compromised sterility due to holes in the packaging.

Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment

The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.

There is a potential that an image from a previous patient study to show up in a later patient study. This may result in misdiagnosis of the correct patient.

Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment

Saline Flush Syringe compromised sterility due to holes in the packaging.

Saline Flush Syringe compromised sterility due to holes in the packaging.

Iincorrectly packaged without the required lidocaine as labeled

Inability for the guidewire to pass through the needles included with the catheter kits.