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Showing 4681–4700 of 8389 results

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ReNewal Ligasure Sealer (MEDLINE) – packaging seal issue (2023)

Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.

FDAAug 3, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

ReNewal Ligasure Maryland Jaw Sealer (MEDLINE) – packaging seal issue (2023)

Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.

FDAAug 3, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

Liquid Assayed Chemistry Control (Randox) – instructions error (2023)

there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice.

Moderate

FDAAug 3, 2023GA, OH, OR +3 more• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Sterile Iris Scissors (MEDLINE) – tip protector risk (2023)

4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector to fall off. The sharp tip of the scissors could compromise the sterile barrier system by puncturing large and/or small holes that may not be visible to the user.

FDAAug 3, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

Gammex Non-Latex PI Green Surgical Gloves (Ansell) – pouch seal issue (2023)

Some surgical glove sterile pouches were not completely sealed.

FDAAug 3, 2023Nationwide• Ansell Healthcare Products LLC

ReNewal Ligasure Blunt Tip Sealer (MEDLINE) – packaging seal issue (2023)

Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.

FDAAug 3, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

Novaplus Gammex Non-Latex PI Green Surgical Gloves (Ansell) – pouch seal issue (2023)

Some surgical glove sterile pouches were not completely sealed.

FDAAug 3, 2023Nationwide• Ansell Healthcare Products LLC

3T Heater Cooler System (LivaNova) – maintenance schedule error (2023)

The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.

FDAAug 3, 2023Nationwide• LivaNova Deutschland GmbH Lindberghstr. 25 Munich Germany

ReNewal Harmonic ACE+7 Shears (MEDLINE) – packaging seal issue (2023)

Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.

FDAAug 3, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

Incisive CT (Philips) – software compliance concerns (2023)

Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be triggered at the optimal time. Issue 2: Use of aborted surview for scan planning will result in deviation from intended scan area. Issue 3: Actual clinical scan with bariatric (Noah) couch will deviate from the intended scan area if surview scan length is greater than 1832mm.

FDAAug 2, 2023Nationwide• Philips Healthcare

GS70H Salus Surgical Table (Skytron) – bluetooth control issue (2023)

When the control of the operating table was used in Bluetooth mode, the operating table continued moving even after releasing the button on the control. Originally, the root cause was thought to be confined to Bluetooth/wireless communications between the control pendant and the surgical table. However, during investigation, Mizuho discovered that the failure could be replicated even in wired mode if communication between the pendant and table were somehow interrupted. The root cause appears to be: if communication between the controller and table is interrupted while a button is pressed, the table does not know if/when a button is released. This occurs in wireless or wired mode.

FDAAug 1, 2023Nationwide• Skytron, LLC

GS70 Salus Surgical Table (Skytron) – bluetooth control issue (2023)

When the control of the operating table was used in Bluetooth mode, the operating table continued moving even after releasing the button on the control. Originally, the root cause was thought to be confined to Bluetooth/wireless communications between the control pendant and the surgical table. However, during investigation, Mizuho discovered that the failure could be replicated even in wired mode if communication between the pendant and table were somehow interrupted. The root cause appears to be: if communication between the controller and table is interrupted while a button is pressed, the table does not know if/when a button is released. This occurs in wireless or wired mode.

FDAAug 1, 2023Nationwide• Skytron, LLC

Cardiosave Hybrid IABP (Datascope) – temperature alarm issue (2023)

Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.

FDAJul 31, 2023Nationwide• Datascope Corp.

Cardiosave Rescue IABP (Datascope) – sensor input failure (2023)

Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.

FDAJul 31, 2023Nationwide• Datascope Corp.

Magnifuse Bone Graft (Medtronic) – incorrect product labeling (2023)

The incorrect product labeling was applied to the product indicating the wrong size of product.

FDAJul 31, 2023Nationwide• Medtronic Sofamor Danek USA Inc

Cardiosave Rescue IABP (Datascope) – autofill failure (2023)

Users were identifying autofill failure conditions on the devices causing pump stops.

FDAJul 31, 2023Nationwide• Datascope Corp.

Cardiosave Hybrid IABP (Datascope) – sensor input failure (2023)

Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.

FDAJul 31, 2023Nationwide• Datascope Corp.

Cardiosave Rescue IABP (Datascope) – temperature alarm issue (2023)

Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.

FDAJul 31, 2023Nationwide• Datascope Corp.

Cardiosave Hybrid IABP (Datascope) – charging problem (2023)

Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge.

FDAJul 31, 2023Nationwide• Datascope Corp.

Cardiosave Rescue IABP (Datascope) – charging problem (2023)

Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge.

FDAJul 31, 2023Nationwide• Datascope Corp.

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