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Showing 2141–2160 of 8393 results

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SECURE 250 mL EVA Container (The Metrix Company) – IV Bag Leak Risk (2024)

A limited number of IV bags have been found to leak during filling.

FDAOct 9, 2024Nationwide• The Metrix Company

SECURE 1000 mL EVA Container (The Metrix Company) – IV Bag Leak Risk (2024)

A limited number of IV bags have been found to leak during filling.

FDAOct 9, 2024Nationwide• The Metrix Company

MEDLINE Medical Convenience Kits (MEDLINE) – Smoke Evacuation Pencil Issue (2024)

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Moderate

FDAOct 9, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

Imed Products Imed EVA Bag 1000 mL (The Metrix Company) – IV Bag Leak Risk (2024)

A limited number of IV bags have been found to leak during filling.

FDAOct 9, 2024Nationwide• The Metrix Company

Vygon 250mL EVA Container (Metrix) – IV Bag Leak (2024)

A limited number of IV bags have been found to leak during filling.

FDAOct 9, 2024Nationwide• The Metrix Company

MONOCRYL Suture (ETHICON) – Component Mix-Up Risk (2024)

Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.

FDAOct 8, 2024AL, AK, AZ +42 more• ETHICON, INC. Calle Durango 2751 Col. Parque Industrial Americas, Juarez Juarez Mexico

Approach Hydro ST Micro Wire Guide (Cook) – Incorrect Expiration Labels (2024)

Affected device lots have labels that state the incorrect expiration dates.

FDAOct 8, 2024Nationwide• Cook Incorporated

Approach CTO Micro Wire Guide (Cook) – Incorrect Expiration Labels (2024)

Affected device lots have labels that state the incorrect expiration dates.

FDAOct 8, 2024Nationwide• Cook Incorporated

LifeVent EVO2 Ventilator (Philips) – Nebulizer Flow Sensor Issue (2024)

Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.

FDAOct 7, 2024Nationwide• Philips Respironics, Inc.

Garbin Evo Ventilator (Philips) – Nebulizer Flow Sensor Issue (2024)

Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.

FDAOct 7, 2024Nationwide• Philips Respironics, Inc.

Trilogy Evo Ventilator (Philips) – Nebulizer Flow Sensor Issue (2024)

Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.

FDAOct 7, 2024Nationwide• Philips Respironics, Inc.

Trilogy EV300 Ventilator (Philips) – Nebulizer Flow Sensor Issue (2024)

Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.

FDAOct 7, 2024Nationwide• Philips Respironics, Inc.

DRG:HYBRiD-XL Insulin (DRG International) – Recalibration Failure (2024)

The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument using the re-calibration R1 and R2 of the device or find controls out of specification (failed Control High) which causes a delay in results.

FDAOct 7, 2024Nationwide• DRG International, Inc.

Philips Zenition 70 (PHILIPS) – Mains Control Unit Fuse Issue (2024)

Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.

FDAOct 7, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Trilogy Evo O2 Ventilator (Philips) – Nebulizer Flow Sensor Issue (2024)

Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.

FDAOct 7, 2024Nationwide• Philips Respironics, Inc.

Trilogy Evo Universal Ventilator (Philips) – Nebulizer Flow Sensor Issue (2024)

Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.

FDAOct 7, 2024Nationwide• Philips Respironics, Inc.

Aeris EVO Ventilator (Philips) – Nebulizer Flow Sensor Issue (2024)

Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.

FDAOct 7, 2024Nationwide• Philips Respironics, Inc.

Philips Zenition 50 (PHILIPS) – Mains Control Unit Fuse Issue (2024)

Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.

FDAOct 7, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

CardioMEMS HF System (St. Jude Medical) – Cloud Data Migration Error (2024)

As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.

FDAOct 5, 2024Nationwide• St. Jude Medical

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

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

FDAOct 4, 2024Nationwide• Stryker Corporation

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