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Hasson Trocar (Aesculap) – Packaging Damage (2024)

The sterile blister packaging may be damaged, and sterility may be compromised.

FDAJan 9, 2024Nationwide• Aesculap Inc

Trocar with Dilating Pin (Aesculap) – Packaging Damage (2024)

The sterile blister packaging may be damaged, and sterility may be compromised.

FDAJan 9, 2024Nationwide• Aesculap Inc

VOCSN Patient Breathing Package (Ventec) – Spiral Wrap Failure (2024)

The bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Detachment of the spiral wrap can compromise structural integrity, functionality and/ or performance resulting in occlusions or leaks of the breathing circuit which may cause serious injury or death. The risk of injury or death is increased for ventilator dependent patients.

Very High

FDAJan 9, 2024CA, CO, FL +5 more• Ventec Life Systems, Inc.

OSOM BVBLUE Control Kit (Mckesson) – Temperature Excursion Risk (2024)

Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes .

FDAJan 9, 2024Nationwide• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

Hasson Trocar (Aesculap) – Packaging Sterility Concern (2024)

The sterile blister packaging may be damaged, and sterility may be compromised.

FDAJan 9, 2024Nationwide• Aesculap Inc

Trocar with Dilating Pin (Aesculap) – Packaging Sterility Concern (2024)

The sterile blister packaging may be damaged, and sterility may be compromised.

FDAJan 9, 2024Nationwide• Aesculap Inc

Endo Cleaning Indicator (Mckesson) – Temperature Excursion Risk (2024)

Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.

FDAJan 9, 2024Nationwide• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

BBL Sensi Disc Cefuroxime (BD) – Testing Accuracy Issue (2024)

There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.

FDAJan 8, 2024Nationwide• Becton Dickinson & Co.

Sensi Disc Amoxicillin/Clavulanic Acid (BD) – Testing Accuracy Issue (2024)

There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.

FDAJan 8, 2024Nationwide• Becton Dickinson & Co.

BBL Sensi Disc Cefaclor (BD) – Testing Accuracy Issue (2024)

There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.

FDAJan 8, 2024Nationwide• Becton Dickinson & Co.

BBL Sensi Disc Ertapenem (BD) – Testing Accuracy Issue (2024)

There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.

FDAJan 8, 2024Nationwide• Becton Dickinson & Co.

BBL Sensi Disc Piperacillin/Tazobactam (BD) – Testing Accuracy Issue (2024)

There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.

FDAJan 8, 2024Nationwide• Becton Dickinson & Co.

BBL Sensi Disc Ceftaroline (BD) – Testing Accuracy Issue (2024)

There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.

FDAJan 8, 2024Nationwide• Becton Dickinson & Co.

BBL Sensi Disc Augmentin (BD) – Testing Accuracy Issue (2024)

There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.

FDAJan 8, 2024Nationwide• Becton Dickinson & Co.

BBL Sensi Disc Cefpodoxime (BD) – Testing Accuracy Issue (2024)

There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.

FDAJan 8, 2024Nationwide• Becton Dickinson & Co.

BBL Sensi Disc Imipenem (BD) – Testing Accuracy Issue (2024)

There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.

FDAJan 8, 2024Nationwide• Becton Dickinson & Co.

RotaFlow Centrifugal Pump (Maquet) – Sterile Barrier Risk (2024)

Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following potential harms: inflammation, infection, or sepsis.

FDAJan 8, 2024Nationwide• Maquet Medical Systems USA

BBL Sensi Disc Rifampin (BD) – Testing Accuracy Issue (2024)

There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.

FDAJan 8, 2024Nationwide• Becton Dickinson & Co.

BBL Sensi Disc Clarithromycin (BD) – Testing Accuracy Issue (2024)

There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.

FDAJan 8, 2024Nationwide• Becton Dickinson & Co.

BBL Sensi Disc Cefotaxime (BD) – Testing Accuracy Issue (2024)

There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.

FDAJan 8, 2024Nationwide• Becton Dickinson & Co.

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