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Showing 3561–3580 of 8389 results

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TRIDENTII HEMI CLUSTER44B (Howmedica Osteonics) – Excessive Shell Deburring (2024)

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

Low

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

Uvula Retractor (Karl Storz) – Reprocessing Validation (2024)

Inadequate reprocessing validation evidence

Moderate

FDAFeb 27, 2024Nationwide• Karl Storz Endoscopy

TRIDENTII HEMI CLUSTER58F (Howmedica Osteonics) – Excessive Shell Deburring (2024)

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

Low

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

TRIDENTII PSL CLUSTER52E (Howmedica Osteonics) – Excessive Shell Deburring (2024)

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

Low

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

TRIDENTII PSL CLUSTER64H (Howmedica Osteonics) – Excessive Shell Deburring (2024)

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

Low

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

TRIDENTII HEMI CLUSTER52E (Howmedica Osteonics) – Excessive Shell Deburring (2024)

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

Low

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

Trident II PSL Cluster (Howmedica) – Acetabular Shell Surface Defect (2024)

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

Low

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

VITROS Performance Verifier I (Ortho-Clinical Diagnostics) – Diluent Mismatch (2024)

The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.

Moderate

FDAFeb 27, 2024Nationwide• Ortho-Clinical Diagnostics

CADD-Solis Ambulatory Pumps (Smiths Medical) – Software Malfunction (2024)

CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following issues:1. Upstream Occlusion, 2. Stop and Power Keys Unresponsive, 3. Manual Mode Air Detector, 4. Single Bubble Air Detection, 5. Error Codes Not Displayed at Power Up, 6. Audible Alarm, 7. Low Sensitivity Air in Line Detection Threshold, 8. PharmGuard Server Password. Smiths Medical corrected many of the issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent CADD software (v4.3 - 2023) installed on your pumps.

Moderate

FDAFeb 27, 2024Nationwide• Smiths Medical ASD Inc.

O.T.D Optimum Traction Device (Emergency Products) – Adhesive Failure (2024)

Failure of adhesive to secure the pole insert.

Moderate

FDAFeb 27, 2024Nationwide• Emergency Products & Research

TRIDENTII HEMI CLUSTER50D (Howmedica Osteonics) – Excessive Shell Deburring (2024)

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

Low

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

Trident II Hemi Cluster (Howmedica) – Acetabular Shell Surface Defect (2024)

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

Low

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

Optical Scissor (Karl Storz) – Reprocessing Validation (2024)

Inadequate reprocessing validation evidence

Moderate

FDAFeb 27, 2024Nationwide• Karl Storz Endoscopy

CADD-Solis VIP Pumps (Smiths Medical) – Infusion Uses (2024)

Laceration Risk

The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.

Moderate

FDAFeb 27, 2024Nationwide• Smiths Medical ASD Inc.

TRIDENTII PSL CLUSTER58F (Howmedica Osteonics) – Excessive Shell Deburring (2024)

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

Low

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

TRIDENTII PSL CLUSTER50D (Howmedica Osteonics) – Excessive Shell Deburring (2024)

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

Low

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

ConvaTec CarboFlex (ConvaTec) – Sterility Assurance Failure (2024)

The product does not meet sterility assurance level.

Moderate

FDAFeb 27, 2024Nationwide• ConvaTec, Inc

TRIDENTII HEMI CLUSTER48D (Howmedica Osteonics) – Excessive Shell Deburring (2024)

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

Low

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

Sub-G Endotracheal Tube (MEDLINE) – Tube Detachment Risk (2024)

Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate. There were also reports the suction pump is difficult to connect or detaches during use.

Moderate

FDAFeb 26, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

Skull Anchor Key (Navinetics) – Attachment Failure (2024)

Defective Skull Anchor Key. After attachment of the single use Skull Anchor Key to the patient, the user was unable to attach the CT Localizer to perform stereotactic Imaging. Attachment of the localizer is typically accomplished by fully screwing in the four thumbscrews of the localizer into the threaded holes found on the top surface of the Skull Anchor Key.

Moderate

FDAFeb 26, 2024Nationwide• Navinetics Inc

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