Other Medical Devices

Complaints of the ceramic tip of the resection sheath breaking have been received.

During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.

Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Knee and Humeral socket implants contain incorrect labeling.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Software anomaly in the patient positioning system may result in positional discrepancy.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Lack of 510K clearance

Complaints of the ceramic tip of the resection sheath breaking have been received.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the issue occur.

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Firm is initiating a removal due to continued reports of adverse events.