All Recalls

Compromised sterility due to breach of barrier

The potential exists within the identified tables that incorrectly manufactured parts have been used in assembly. If a table is found to have these incorrectly manufactured parts, it is possible for the tables elevation column slide cap to become detached from the elevation column and could result in the loss of control of the table top and injury to the patient or staff.

These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.

During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment.

Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.

Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.

Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.

Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the Dimension Vista System omitting an aliquot probe rinse between sample aspirations when processing tubes in Sample Racks that are front loaded on the Dimension Vista System.

Compromised sterility due to breach of barrier

Compromised sterility due to breach of barrier

This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.

Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SAL) of 10-6 is not achieved on torque limiting devices when subjected to steam sterilization cycles identified in the Instruction For Use (IFU) provided with the device.

Stat-check CO2 indicators are non-functional. The indicator is yellow when not in use and should be purple when not in use. The yellow indicates a 5% CO2 level, cardiac massage and ventiliation being performed correctly. The color will not change during use and will not be an indicator of CO2 level or improper performance of cardiac message and ventilation.

Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.

This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.

Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the Dimension Vista System omitting an aliquot probe rinse between sample aspirations when processing tubes in Sample Racks that are front loaded on the Dimension Vista System.

The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.

One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle.

Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is connected during a surgical procedure.

These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.