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TRIDENTII HEMI CLUSTER66H (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.

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.

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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)

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

Blood Pressure Unit (MEDLINE) – Manufacturing Specification (2024)

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

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

Centurion Forcep Kit (MEDLINE) – Weak Seal Risk (2024)

MEDLINE Wire Cut Scissors (MEDLINE) – Weak Seal Risk (2024)

Centurion PICC Line Kit (MEDLINE) – Weak Seal Risk (2024)

Centurion Sterile Trach Brush (MEDLINE) – Weak Seal Risk (2024)

ACUSON Redwood Ultrasound (Siemens) – Cardiac Measurement Error (2024)

LeadCare II Blood Test (Magellan) – Calibration Mislabeling (2024)

Centurion Backhaus Towel Clamp (MEDLINE) – Weak Seal Risk (2024)

Centurion Buck Ear Curette (MEDLINE) – Weak Seal Risk (2024)

Centurion Senn Retractor (MEDLINE) – Weak Seal Risk (2024)

Centurion Blood Collection Tube (MEDLINE) – Weak Seal Risk (2024)

MEDLINE Swabsticks Alcohol (MEDLINE) – Weak Seal Risk (2024)

MEDLINE Swabsticks PVP (MEDLINE) – Weak Seal Risk (2024)