Search U.S. Product Recalls Database

Showing 3581–3600 of 22584 results

Sort:

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

The product does not meet sterility assurance level.

FDAFeb 27, 2024Nationwide• ConvaTec, Inc

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

FDA

Stay Informed

Search Product Recalls

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

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

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

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

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

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

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

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

Karl Storz Grasping Forceps (Karl Storz) – Reprocessing Validation Inadequacy (2024)

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

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

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

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

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

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

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

TRIDENTII HEMI CLUSTER66H (Howmedica Osteonics) – Excessive Shell Deburring (2024)

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

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

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