Other Medical Devices

Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the handpiece and the generator receptacle leading to risk of cross-contamination if the generator is reused.

A misaligned pipette tip sensor poses the remote risk of cross-contamination when failing to cause a no-tip error, resulting in pipetting patient samples without pipette tips.

There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.

Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.

Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the handpiece and the generator receptacle leading to risk of cross-contamination if the generator is reused.

BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead in blood samples when used with Magellan Diagnostics LeadCare assays, employing the Anodic Stripping Voltammetry (ASV) methodology, or any other assay employing ASV methodology.

The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.

Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause patient health risk. The NxStage PureFlow B Solution is for use with systems that use one premixed dialysate during hemodialysis. The original labeling did not warn against mixing dialysate formulations and did not instruct staff to verify that the fluid is flowing during use.

Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.

The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.

Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.

There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.

Convenience Kit containing components to assist practitioner with IV placement and securement.

Convenience Kit containing components to assist practitioner with IV placement and securement.

Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use.

Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.

Belts on the x-axis (and on the y-axis, to a lesser extent) manufactured from 2015 are showing premature failure, posing the remote risk of cross-contamination.

Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.

Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the handpiece and the generator receptacle leading to risk of cross-contamination if the generator is reused.

Convenience Kit containing components to assist practitioner with IV placement and securement.