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TriALTIS Torque Limiter (Gauthier) – Torque Output Error (2024)

An out of specification component may result in the device exhibiting torque output higher than the design specification.

Moderate

FDANov 11, 2024Nationwide• Gauthier Biomedical, Inc.

O&M Halyard Procedure Mask (O&M Halyard) – Bioburden Testing (2024)

Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.

Moderate

FDANov 8, 2024Nationwide• O & M HALYARD, INC.

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TriALTIS Torque Limiter (Gauthier) – Torque Output Error (2024)

O&M Halyard Procedure Mask (O&M Halyard) – Bioburden Testing (2024)

Panther Fusion COVID/Flu Assay (Hologic) – False Positive Risk (2024)

O&M Halyard Soft Touch Surgical Mask (O&M Halyard) – Bioburden Testing (2024)

Cardinal Health Presource Kits (Cardinal Health) – Endotoxin Risk (2024)

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

DiaSorin LIAISON Q.S.E.T. Device (Diasorin) – Leaking Device (2024)

Septoplasty Pack Convenience Kit (Medline) – Endotoxin Level (2024)

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

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

Spine LH Convenience Kit (Medline) – Endotoxin Level (2024)

Major Neuro Pack Convenience Kit (Medline) – Endotoxin Level (2024)

BD BBL Sensi Disc Ampicillin (Becton Dickinson) – Potency Decrease (2024)

ChemoLock Vial Spike (ICU Medical) – Packaging Error (2024)

Merlin.net PCN Heart Failure Web App (St. Jude) – Data Migration Issue (2024)

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

FESS-MB Pack Convenience Kit (Medline) – Endotoxin Level (2024)

DIEP FLAP Convenience Kit (Medline) – Endotoxin Level (2024)

Medline Procedure Convenience Kits (Medline) – Endotoxin Level (2024)

V.A.C. Ulta Therapy Unit (KCI) – System Error Alarm (2024)