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20/30 INDEFLATOR (Abbott Vascular) – Connection Leak Risk (2022)

Due to an increase in complaint trend for leaks and intermittent/loose connections.

FDAMar 11, 2022Nationwide• Abbott Vascular

Virus Counter Platform (Sartorius) – Non-Medical Device (2022)

The Virus Counter is an automated laboratory instrument that enables rapid quantification of intact viruses in solution. This instrument is not a medical device. The virus quantification is used in process development and manufacturing of various biotechnology products such as vaccines, gene therapy and personalized immunotherapy. Device is a Class 1 laser flow cytometer.

FDAMar 11, 2022Nationwide• Sartorius Corporation

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20/30 INDEFLATOR (Abbott Vascular) – Connection Leak Risk (2022)

Virus Counter Platform (Sartorius) – Non-Medical Device (2022)

Abbott Priority Pack (Abbott Vascular) – Connection Leak Risk (2022)

Abbott Priority Pack (Abbott Vascular) – Connection Leak Risk (2022)

INDEFLATOR Plus 30 (Abbott Vascular) – Connection Leak Risk (2022)

Plus 30 Priority Pack (Abbott Vascular) – Connection Leak Risk (2022)

Gallant DR Defibrillator (St. Jude Medical) – Bluetooth Malfunction (2022)

Merlin PCS Programmer (St. Jude Medical) – Software Anomaly (2022)

Gallant HF Defibrillator (St. Jude Medical) – Bluetooth Malfunction (2022)

Merlin 2 PCS Programmer (St. Jude Medical) – Software Anomaly (2022)

EasyFuse Dynamic Compression System (Wright Medical) – Instrument Jam Risk (2022)

Gallant VR Defibrillator (St. Jude Medical) – Bluetooth Malfunction (2022)

Medline Laryngeal Masks (Medline) – Mask Disconnection Risk (2022)

OES Bronchofiberscope (Olympus) – Reprocessing Instructions (2022)

EVIS EXERA Bronchofibervideoscope (Olympus) – Reprocessing Instructions (2022)

ROTAWIRE Drive (Boston Scientific) – Sterility Compromise (2022)

OnGuard2 CSTD Bag Adaptor (Simplivia) – Medication Spillage Risk (2022)

EVIS EXERA II Bronchovideoscope (Olympus) – Reprocessing Instructions (2022)

EVIS EXERA Bronchovideoscope (Olympus) – Reprocessing Instructions (2022)

ARCHITECT Myoglobin Calibrators (Abbott) – Testing Accuracy Issue (2022)