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Arial Call Station (Securitas) – Nurse Call System Problem (2024)

This is a risk that alarms will not be received by the Arial Wireless Nurse Call System and premature depletion of the battery.

High

FDAJun 20, 2024AL, CA, FL +10 more• Securitas Healthcare LLC

Verigene Blood Culture Test (Luminex) – False Positive Risk (2024)

Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.

Moderate

FDAJun 20, 2024Nationwide• Luminex Corporation

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Arial Call Station (Securitas) – Nurse Call System Problem (2024)

Verigene Blood Culture Test (Luminex) – False Positive Risk (2024)

UNITRAX Endoprosthesis Head (Howmedica) – Mislabeling Issue (2024)

BioFire Blood Culture Panel (BioFire) – False Positive Concern (2024)

Anesthesia Turnover Kit (Medline) - Non-sterile Component (2024)

FoundationOne CDx (Foundation Medicine) – Report Discrepancy (2024)

BD Nano Pen Needles (Embecta) – Expiration Date Concern (2024)

Craniotomy Pack (Medline) – Sterility Labeling Problem (2024)

Soft-VU Kumpe 5F X 40CM (Angiodynamics) – Mislabeling Issue (2024)

Soft-VU Kumpe 5F X 65CM (Angiodynamics) – Mislabeling Issue (2024)

Pediatric Craniotomy Kit (Medline) – Sterility Labeling Issue (2024)

Infusomat Space Pump Set (B. Braun) - Backflow Risk (2024)

Outlook IV Set (B. Braun) - Backflow Risk (2024)

Infusomat Space Pump IV Set (B. Braun) - Backflow Risk (2024)

Outlook IV Set (B. Braun) - Backflow Risk (2024)

Mega Soft Patient Electrode (Megadyne) - Age Limitation (2024)

Infusomat Universal Pump Set (B. Braun) - Backflow Risk (2024)

Infusomat Universal Pump Set (B. Braun) - Backflow Risk (2024)

Infusomat Metriset Pump Set (B. Braun) - Backflow Risk (2024)

Infusomat Space Pump IV Set (B. Braun) - Backflow Risk (2024)