Medical Devices Recalls

Incomplete seals on the sterile package may compromise the sterility

Incomplete seals on the sterile package may compromise the sterility

Incomplete seals on the sterile package may compromise the sterility

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

Incomplete seals on the sterile package may compromise the sterility

Incomplete seals on the sterile package may compromise the sterility

The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

Firm has received reports of leading end catheter component separations.

The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

The firm was unsuccessful in obtaining a satisfactory Certificate of Conformance from the original vendor of the mattress showing that they are in compliance with labeling requirements.

Incomplete seals on the sterile package may compromise the sterility

Potential for leakage at the joint between the blood filters and tubing

Incomplete seals on the sterile package may compromise the sterility

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

Fetal transducers distributed in advance of receiving 510(k) and international clearances.

The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (¿ 0.2¿C for Genius 2 and ¿ 0.3¿C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2¿C for Genius 2 or +0.3¿C for Genius 3.

The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

Incomplete seals on the sterile package may compromise the sterility

The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

Exhibiting a reversed image. Although the image may appear normal, the users actions will be reversed on the display for left and right directions.