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Sertera Biopsy Device (Hologic) – Needle Detachment (2023)

The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery

FDAMay 2, 2023Nationwide• Hologic, Inc

V-Sign Sensor 2 (SenTec) – Calibration Failure (2023)

The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset to "released" mode.

Moderate

FDAMay 2, 2023Nationwide• SenTec AG Ringstrasse 39 Therwil Switzerland

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Sertera Biopsy Device (Hologic) – Needle Detachment (2023)

V-Sign Sensor 2 (SenTec) – Calibration Failure (2023)

ENGAGE Knee System (Smith & Nephew) – High Revision Rate (2023)

Serrated Blade Applicator Kit (Helena) – Packaging Mismatch (2023)

FentaNYL Syringe Injection (Apollo Care) – Sterility Concerns (2023)

Vancomycin Sodium Chloride (Apollo Care) – Sterility Assurance Lack (2023)

Norepinephrine Dextrose (Apollo Care) – Sterility Assurance Lack (2023)

Norepinephrine Sodium Chloride Injection (Apollo Care) – Sterility Concerns (2023)

VANComycin Sodium Chloride Injection (Apollo Care) – Sterility Concerns (2023)

PHENYLephrine HCl Injection (Apollo Care) – Sterility Concerns (2023)

Vancomycin Sodium Chloride (Apollo Care) – Sterility Assurance Lack (2023)

Fentanyl Ropivacaine Injection (Apollo Care) – Sterility Assurance Lack (2023)

Vancomycin Sodium Chloride (Apollo Care) – Sterility Assurance Lack (2023)

Vancomycin Sodium Chloride (Apollo Care) – Sterility Assurance Lack (2023)

Ketamine Injection (Apollo Care) – Sterility Assurance Lack (2023)

Vancomycin Sodium Chloride (Apollo Care) – Sterility Assurance Lack (2023)

Vancomycin Sodium Chloride (Apollo Care) – Sterility Assurance Lack (2023)

Vancomycin Sodium Chloride (Apollo Care) – Sterility Assurance Lack (2023)

Succinylcholine Injection (Apollo Care) – Sterility Assurance Lack (2023)

VANComycin Sodium Chloride Injection (Apollo Care) – Sterility Concerns (2023)