All Recalls

Lack of assurance of sterility.

Lack of assurance of sterility.

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Lack of assurance of sterility.

Lack of assurance of sterility.

Lack of assurance of sterility.

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .

Lack of assurance of sterility.

Lack of assurance of sterility.

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Lack of assurance of sterility.

Inner pouch seal may be inadequate resulting in lack of sterility.

Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.

The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system.

There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the possible failure of a component in the electrical system of the Product.

Labeling error.

Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.

Reports received of torn corrugated breathing tubes.

The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.

The battery wiring harness on affected wheelchairs may become disconnected during shipment from the factory or during wheelchair use traversing large obstacles or after a jolt or impact to the wheelchair. The disconnection of the battery harness results in loss of power to the wheelchair.