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Carrollton Hip FX Kit (MEDLINE) – Packaging Seal Defect (2024)

Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.

Low

FDAOct 4, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

Stryker Neptune SafeAir Smoke Evacuation Pencil (Stryker) – Activation Malfunction (2024)

Fire/Burn Risk

There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries

High

FDA

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Carrollton Hip FX Kit (MEDLINE) – Packaging Seal Defect (2024)

Stryker Neptune SafeAir Smoke Evacuation Pencil (Stryker) – Activation Malfunction (2024)

Stryker Neptune SafeAir Smoke Pencil (Stryker) – Activation Malfunction (2024)

Posi-Stop 23G Injection Needle (Hobbs Medical) – Flow Obstruction Risk (2024)

Posi-Stop 25G Injection Needle (Hobbs Medical) – Flow Obstruction Risk (2024)

microTargeting Insertion Tube Set (FHC) – Spacer Tube Design Issue (2024)

FreeStyle Comfort Oxygen Concentrator (Caire) – Battery Recharge Failure (2024)

Children's General TracePack (DeRoyal) – Smoke Evacuation Pencil Issue (2024)

Children's Orthopedic TracePack (DeRoyal) – Smoke Evacuation Pencil Issue (2024)

Children's LapTracePack (DeRoyal) – Smoke Evacuation Pencil Issue (2024)

Centricity Universal Viewer (GE Healthcare) – Security Vulnerability (2024)

C-Section TracePack (DeRoyal) – Smoke Evacuation Pencil Issue (2024)

Medtronic DLP Aortic Root Cannula (Medtronic) – Potential Sterility Breach (2024)

MEERA CL Mobile Operating Table (Getinge) – Control System Error (2024)

RENASYS EDGE Pump (Smith & Nephew) – Battery Maintenance Issue (2024)

Legion Oxinium Constrained Femoral Component (Smith & Nephew) – Implant Mislabeling (2024)

TEMA Elbow Axle (Limacorporate) – Mechanical Behavior Difference (2024)

Legion Oxinium Posterior Stabilized Component (Smith & Nephew) – Implant Mislabeling (2024)

Genesis II Posterior Stabilized Femoral Component (Smith & Nephew) – Implant Mislabeling (2024)

Spectrum IQ Infusion System (Baxter) – Door Closure Malfunction (2024)