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Reprocessed Bruns Curette (Medline) – Sterility Seal Weakness (2024)

Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.

FDANov 12, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

Rummell Instrument (Medline) – Sterility Seal Weakness (2024)

Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.

FDANov 12, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

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Reprocessed Bruns Curette (Medline) – Sterility Seal Weakness (2024)

Rummell Instrument (Medline) – Sterility Seal Weakness (2024)

O.R. Scissors (Medline) – Sterility Seal Weakness (2024)

Mayo Hegar Needleholder (Medline) – Sterility Seal Weakness (2024)

Access Intact PTH Assay (Beckman Coulter) – Sample Storage Issue (2024)

Abbott 20/30 Priority Pack Kit (Abbott) – Inflation Device Leak (2024)

Abbott 20/30 Indeflator (Abbott) – Inflation Device Leak (2024)

Abbott 20/30 Priority Pack Kit (Abbott) – Inflation Device Leak (2024)

Atellica CI Analyzer (Siemens) – Diluent Volume Issue (2024)

FACSLyric 3L8C Instrument (BD) – power supply module issue (2024)

FACSLyric 2L6C Instrument (BD) – power supply module issue (2024)

FACSLyric 3L10C Instrument (BD) – power supply module issue (2024)

FACSLyric 2L4C Instrument (BD) – power supply module issue (2024)

FACSLyric 3L12C Instrument (BD) – power supply module issue (2024)

PORTEX Tracheal Tube Exchange Guide (Smiths Medical) – fluid ingress risk (2024)

PORTEX Venn Tracheal Tube Introducer (Smiths Medical) – fluid ingress risk (2024)

Galaxy System (Noah Medical) – power supply circuit risk (2024)

JuggerLoc Drill Guide (Biomet) – Packaging Deformation (2024)

Essenz HLM (LivaNova) – Touchscreen Interruption (2024)

Defibtech Adult Defibrillation Pads (Defibtech) – Labeling Issue (2024)