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Showing 10961–10980 of 35905 results

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Fentanyl Ropivacaine Injection (Apollo Care) – Sterility Assurance Lack (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2023MO• Apollo Care, LLC

Vancomycin Sodium Chloride (Apollo Care) – Sterility Assurance Lack (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2023MO• Apollo Care, LLC

Vancomycin Sodium Chloride (Apollo Care) – Sterility Assurance Lack (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2023MO• Apollo Care, LLC

Ketamine Injection (Apollo Care) – Sterility Assurance Lack (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2023MO• Apollo Care, LLC

Vancomycin Sodium Chloride (Apollo Care) – Sterility Assurance Lack (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2023MO• Apollo Care, LLC

Vancomycin Sodium Chloride (Apollo Care) – Sterility Assurance Lack (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2023MO• Apollo Care, LLC

Vancomycin Sodium Chloride (Apollo Care) – Sterility Assurance Lack (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2023MO• Apollo Care, LLC

Succinylcholine Injection (Apollo Care) – Sterility Assurance Lack (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2023MO• Apollo Care, LLC

VANComycin Sodium Chloride Injection (Apollo Care) – Sterility Concerns (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2023MO• Apollo Care, LLC

S 580 E (Mercedes-Benz) – Battery Thermal Management (2023)

Mercedes-Benz USA, LLC (MBUSA) is recalling certain 2023 EQE 350, S580e, 2022-2023 EQS 450, EQS 580, 2022 AMG EQS 53, and EQS 450+ vehicles. The high-voltage battery monitoring system software may not alert the driver of a battery malfunction. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 305, "Electric-powered vehicles: Electrolyte Spillage and Electrical Shock Protection."

NHTSAMay 2, 2023Nationwide• MERCEDES-BENZ

Allegro Breeze (Tiffin) – RV Equipment (2020)

Tiffin Motorhomes, Inc. (Tiffin) is recalling certain 2020-2023 Breeze motorhomes. The condensation pan under the refrigerator may overflow and leak into the Molex electrical connections on the floor.

NHTSAMay 1, 2023Nationwide• TIFFIN

Veritor SARS-CoV-2/Flu Test (BD) – IFU Approval (2023)

IFU- Instructions for Use (IFU) package insert and both the IFU packaged with the test kit and the electronic version on the BD website not approved by FDA,specifically describing specimen type, could cause use of the test with invalid specimen types, which may produce false positive or false negative results.Erroneous results can cause a delay in diagnosis or treatment

FDAMay 1, 2023Nationwide• Becton Dickinson & Co.

Trilogy Evo Ventilator (Philips) – Sensor Debris (2023)

Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.

FDAMay 1, 2023Nationwide• Philips Respironics, Inc.

EliA GliadinDP IgG Well (Phadia) – Result Variation (2023)

Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument

FDAMay 1, 2023CA, MI, NJ• Phadia US Inc

Trilogy Evo Universal Ventilator (Philips) – Ventilation Issue (2023)

The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and pulse rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional and hospital settings and non-emergency transport settings; for example, wheelchair. It may be used for both invasive and non-invasive ventilation.

FDAMay 1, 2023Nationwide• Philips Respironics, Inc.

Phadia 2500EE Instrument (Phadia) – Result Variation (2023)

Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument

FDAMay 1, 2023CA, MI, NJ• Phadia US Inc

Trilogy Evo O2 EV300 (Philips) – Sensor Debris (2023)

Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.

FDAMay 1, 2023Nationwide• Philips Respironics, Inc.

Trilogy Evo O2/LifeVent (Philips) – Sensor Debris (2023)

Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.

FDAMay 1, 2023Nationwide• Philips Respironics, Inc.

Pyrazinamide Tablet 500mg (RemedyRepack) – Quality Program Issue (2023)

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

Class IIModerate

FDAMay 1, 2023IN, PA• RemedyRepack Inc.

Ketotifen Fumarate Eye Drops (RemedyRepack) – Quality Program Issue (2023)

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

Class IIModerate

FDAMay 1, 2023IN, PA• RemedyRepack Inc.

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