Other Medical Devices

Complaints were received that reported the stopcock of some Stopcock Extension Sets are assembled in the reverse position, resulting in the stopcock being closed when set in the open position and vise versa.

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

STERIS has identified that deformation of the washers door handle pin may occur when the door handle is rotated with sufficient force. Should deformation and/or breakage of the door handle pin occur there is a potential for the washer door to become inoperable.

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect packaging integrity.

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

Product may not have been manufactured pursuant to a validated process protocol and CGMP.

KARL STORZ Endoscopy-America is recalling the Essential NEO because the connected power cable could potentially become overheated and result in smoke being generated and the cessation of function of the peripheral that the cable is connected to.

An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.

The temperature sensor/control system in the HLD Systems Model 610 may provide a false temperature reading. This caused the water to remain at ambient temperature throughout the pasteurization cycle rather than using hot water.

Straps may separate from the foam pad.

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.