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Acyclovir Sodium Injection (Eugia US) – particulate matter (2022)

Presence of Particulate Matter: Customer complaint of dark particles found inside the vial

FDADec 28, 2022Nationwide• Eugia US LLC

Medline Sterile Hand Pack (Medline) – Improper Sterilization (2022)

The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.

Moderate

FDADec 27, 2022Nationwide• MEDLINE INDUSTRIES, LP Northfield

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Acyclovir Sodium Injection (Eugia US) – particulate matter (2022)

Medline Sterile Hand Pack (Medline) – Improper Sterilization (2022)

Medline Maximum Barrier Pack (Medline) – Improper Sterilization (2022)

MyDay & Reveal Toric Contacts (CooperVision) – Incorrect Power (2022)

Medline Oncology Port Access Tray (Medline) – Improper Sterilization (2022)

Incisive CT Scanner (Philips) – Software Misdiagnosis Risk (2022)

Centurion VAD Drive (Medline) – Expired Component (2022)

Precision Delivery Set (Quest Medical) – Tubing Detachment Risk (2022)

LinkSymphoKnee Augment (Waldemar Link) – Screw Orientation Error (2022)

Medline Foot & Ankle Drill Bit (Medline) – Screw Failure Risk (2022)

Getinge Flow-i Anesthesia System (Getinge) – Ventilation Risk (2022)

myNeedle Guide Software (Siemens) – Orientation Label Error (2022)

Getinge Flow-c Anesthesia System (Getinge) – Ventilation Risk (2022)

RipCord Syndesmosis Button (TriMed) – Tension Failure Risk (2022)

HydroMID Catheter Kit (Access Vascular) – Mislabeling Issue (2022)

Air-Q3 Airway Device (SunMed) – Tube Size Discrepancy (2022)

ADVIA Centaur HBeAg Test (Siemens) – Interference Risk (2022)

HydroMID Catheter Kit (Access Vascular) – Incorrect Label (2022)

EMPOWR VVC Knee Insert (Unknown) – Size Label Swap (2022)

Covera Vascular Stent (Bard) – Deployment Problem (2022)