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PosiFlush Saline Syringe (BD) – Incorrect Stopper (2023)

An incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with General Pump Compatibility. The use of BD PosiFlush Prefilled Flush Syringes with this stopper causes an increase in injection force, which has the potential to trigger alarms if used with a syringe pump.

Moderate

FDANov 16, 2023Nationwide• Becton Dickinson & Company

AbsorbaTack Fixation Device – Packaging Seal Weakness (2023)

Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product sterility

Low

FDANov 16, 2023Nationwide

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PosiFlush Saline Syringe (BD) – Incorrect Stopper (2023)

AbsorbaTack Fixation Device – Packaging Seal Weakness (2023)

Valleylab FT10 Energy Platform (Covidien) – Software Issue (2023)

V. Mueller Bandage Scissors (Steris) – Color Residue Issue (2023)

X-ray System (Canon) – Detector Image Abnormality (2023)

Guardian 4 Glucose Sensor (Medtronic) – GOX Layer Thickness (2023)

Medline Suction Cath Kit (Medline) – Sodium Chloride Issue (2023)

Baxter Amia Dialysis Cycler – Wet Cassette Test Failures (2023)

Centurion Kits (Medline) – Sodium Chloride Issue (2023)

SoClean 2 (SoClean) – User Manual Update (2023)

Medline Bronchoscopy Tray (Medline) – Sodium Chloride Issue (2023)

Sensica Urine Output System (Bard) – WiFi Time Display (2023)

INFX-8000F (Canon) – Detector Image Abnormality (2023)

SoClean 3 (SoClean) – User Manual Update (2023)

Turbo-Elite Laser Catheter (Spectranetics) – Labeling Error (2023)

Arterial Bundle (Medline) – Sodium Chloride Issue (2023)

Trach Basic Solution Tray (Medline) – Sodium Chloride Issue (2023)

Tracheostomy Tray (Medline) – Sodium Chloride Issue (2023)

Cath Lab CDS Kit (Medline) – Sodium Chloride Issue (2023)

Recanalization System (Bard) – Continuous Run Mode (2023)