Medical Devices Recalls

During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the guidance may lead to over diluted, under diluted, or improperly lysed sample, which in turn could lead to false negative or false positive results.

Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.

Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation

Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible with the upgraded version of the Leoni Plus ventilator, manufactured by Lowenstein Medical. The Leoni Plus ventilator was recently upgraded in 2021 by Lowenstein Medical, with new hardware and software, and the upgraded version cannot be appropriately connected with the INOmax DSIR as instructed in the INOmax DSIR Operators Manual (OM). The INOmax DSIR OM requires the use of a one-way valve with the Leoni Plus ventilator during High Frequency Oscillatory Ventilation mode and warns that use of the device without a one-way valve may result in high Nitric Oxide (NO) delivery.

Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use.

Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Potential for incomplete seals.