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INOmax DSIR (Mallinckrodt) – Ventilator Compatibility Issue (2022)

The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible with the upgraded version of the Leoni Plus ventilator, manufactured by Lowenstein Medical. The Leoni Plus ventilator was recently upgraded in 2021 by Lowenstein Medical, with new hardware and software, and the upgraded version cannot be appropriately connected with the INOmax DSIR as instructed in the INOmax DSIR Operators Manual (OM). The INOmax DSIR OM requires the use of a one-way valve with the Leoni Plus ventilator during High Frequency Oscillatory Ventilation mode and warns that use of the device without a one-way valve may result in high Nitric Oxide (NO) delivery.

FDAJun 23, 2022Nationwide• Mallinckrodt, LLC.

CereLink ICP Monitor (Integra) – Pressure Reading Drift Problem (2022)

Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message "sensor or extension cable failure!" The firm has found that this is caused by electrical interference from a component of the monitor's circuit board and from the environment.

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INOmax DSIR (Mallinckrodt) – Ventilator Compatibility Issue (2022)

CereLink ICP Monitor (Integra) – Pressure Reading Drift Problem (2022)

Cobalt Implantable Cardioverter Defibrillator (Medtronic) – Reduced Shock Energy (2022)

E-100 Generator (Intuitive Surgical) – Maintenance Performance Issue (2022)

CVS Health Surgical Pads (ASO) – Product Disintegration Problem (2022)

Revogene (Meridian Bioscience) – Cooling Period Safety Issue (2022)

Crome Implantable Cardioverter Defibrillator (Medtronic) – Reduced Shock Energy (2022)

etouchus Blood Glucose Meter (Touch US) – FDA Clearance Missing (2022)

AquaC UNO H (Fresenius) – Ethernet Cable Ferrite Core Missing (2022)

AquaC UNO H Reverse Osmosis Unit (Fresenius) – Electromagnetic Compatibility Issue (2022)

BD Intraosseous Needle Kit (Bard Access) – Stylet Removal Risk (2022)

Simplify Disc (NuVasive) – UDI Barcode Error (2022)

Verigene CDF Test (Luminex) – False Negative Risk (2022)

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

Merlin.net Software (St. Jude Medical) – Programming System Design (2022)

Merlin 2 PCS Programmer (St. Jude Medical) – Programming System Design (2022)

VERIGENE Enteric Pathogens Test (Luminex) – False Negative Risk (2022)

Neurology Packs (American Contract) – Sterilization Cycle Concern (2022)

PICC Line Packs (American Contract) – Sterilization Cycle Concern (2022)

Laparoscopy Packs (American Contract) – Sterilization Cycle Concern (2022)