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Medex Stopcock (Smiths Medical) – O-ring Size (2023)

There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.

Moderate

FDANov 10, 2023Nationwide• Smiths Medical Asd Inc

Logical Cath Lab Kit (Smiths Medical) – O-ring Size (2023)

Moderate

FDANov 10, 2023Nationwide• Smiths Medical Asd Inc

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Medex Stopcock (Smiths Medical) – O-ring Size (2023)

Logical Cath Lab Kit (Smiths Medical) – O-ring Size (2023)

Stopcock Rotator (Smiths Medical) – O-ring Size (2023)

High Pressure Rotator (Smiths Medical) – O-ring Size (2023)

EZDilate Wire Balloon 6-7-8 (Olympus) – Balloon Performance (2023)

EMPOWR Knee System (DJO) – Packaging Error (2023)

EZDilate Wire Balloon 8.5-9.5-10.5 (Olympus) – Balloon Performance (2023)

EZDilate Fixed Wire Balloon 6-7-8 (Olympus) – Balloon Performance (2023)

Medex Injection Line (Smiths Medical) – O-ring Size (2023)

Prismalix OR Light System (Getinge) – Fall Risk (2023)

G8 OR Light System (Getinge) – Fall Risk (2023)

Axcel OR Light System (Getinge) – Fall Risk (2023)

Orchide OR Light System (Getinge) – Fall Risk (2023)

Mission Biopsy Instrument Kit (Bard) – Cannula Diameter (2023)

XTen OR Light System (Getinge) – Fall Risk (2023)

Hanaulux Light System (Getinge) – Fall Risk (2023)

Maquet OR Light System (Getinge) – Fall Risk (2023)

PowerLED OR Light System (Getinge) – Fall Risk (2023)

Lucea OR Light System (Getinge) – Fall Risk (2023)

Hanaulux HLX2000 Light System (Getinge) – Fall Risk (2023)