All Recalls

Their is the potential for distal tip separation at the proximal marker band of the delivery catheters

Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating

Blackout curtains are no longer recommended as a protective barrier against UV/Ozone exposure to a bystander standing in the same room, but on the other side of the curtain from where a microbial reduction device UV cycle is taking place. Bystanders in the room during the cycle may experience temporary skin reddening, feeling of sand in eyes, nausea, headache, and/or mucous membrane irritation.

Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.

Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from an incorrect assignment of the carryover value set for created or edited protocols.

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message 'Error - 6013: Has cap, no retention bar." Abbott has identified an issue concerning the use of certain third-party Universal Transport Medium (UTM) tubes on the Alinity m System. This issue has been observed with Copan UTM-RT 3 mL Without Beads Transport & Preservation Medium for Viral Molecular Diagnostics Testing, Part Number (PN) 3C047N. However, it is possible that other third party manufactured tubes could experience the same issue.

Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment

Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2.

Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Their is the potential for distal tip separation at the proximal marker band of the delivery catheters

There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result.

Product demonstrates low viscosity.

Possible failure of Uninterruptable Power Supply (UPS) devices supporting the Patient Information Center (PIC) iX system, potential for the associated PIC iX system to shut down due to the lack of power. may lead to the delay in the detection of a change in a patient condition

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell