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Showing 6141–6160 of 11714 results

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Indomethacin Capsules (Glenmark) – Labeling Mix-Up (2023)

Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

Class IIModerate

FDANov 7, 2023Nationwide• Glenmark Pharmaceuticals Inc., USA

Navik 3D v2 (APN Health) – IFU Update (2023)

IFU update

Low

FDANov 7, 2023Nationwide• APN Health LLC

CARDIOHELP-i System (Maquet) – Factory Settings (2023)

Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor (VBS) and the automatic lock in the Minimized Extracorporeal Circulation (MECC) ThApp

Moderate

FDANov 6, 2023Nationwide• Maquet Medical Systems USA

0.9% Sodium Chloride (Nurse Assist) – sterility concern (2023)

Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.

Very High

FDANov 6, 2023Nationwide• Nurse Assist, LLC

AC Power Adapter (Physio-Control) – battery charging issue (2023)

AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA.

High

FDANov 6, 2023Nationwide• Physio-Control, Inc.

0.9% Sodium Chloride (Nurse Assist) – sterility concern (2023)

Very High

FDANov 6, 2023Nationwide• Nurse Assist, LLC

Fountain Microcatheter (Merit Medical) – sterility risk (2023)

The sterility of microcatheter and infusion system devices cannot be guaranteed.

Very High

FDANov 6, 2023Nationwide• Merit Medical Systems, Inc.

Sterile Water/Saline (Nurse Assist) – sterility concern (2023)

Very High

FDANov 6, 2023Nationwide• Nurse Assist, LLC

Sterile Water/Saline (Nurse Assist) – sterility concern (2023)

Very High

FDANov 6, 2023Nationwide• Nurse Assist, LLC

SEROLOGY ToRCH lgM (Randox) – reactivity decrease (2023)

A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL.

Moderate

FDANov 6, 2023NY, WV• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Merit Pursue Microcatheter (Merit Medical) – sterility risk (2023)

The sterility of microcatheter and infusion system devices cannot be guaranteed.

Very High

FDANov 6, 2023Nationwide• Merit Medical Systems, Inc.

Cricothyrotomy Field Kit (Sarnova) – tube holder incompatibility (2023)

It was determined that the Endotracheal Tube Holder included in certain kits is not compatible with a cricothyrotomy procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.

High

FDANov 6, 2023Nationwide• Sarnova HC, Llc

Field Cric Kit (Sarnova) – tube holder incompatibility (2023)

High

FDANov 6, 2023Nationwide• Sarnova HC, Llc

Sterile Water (Nurse Assist) – Sterility Concern (2023)

High

FDANov 6, 2023Nationwide• Nurse Assist, LLC

ENDOEYE HD II Videoscope (Olympus) – image coloration (2023)

Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal injury or bleeding may occur.

Moderate

FDANov 6, 2023Nationwide• Olympus Corporation of the Americas

Merit Maestro Microcatheter (Merit Medical) – sterility risk (2023)

The sterility of microcatheter and infusion system devices cannot be guaranteed.

Moderate

FDANov 6, 2023Nationwide• Merit Medical Systems, Inc.

Sterile PVP Solution (Medline) – non-sterile contents (2023)

The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.

High

FDANov 3, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

Allura Systems (Philips) – ceiling mount collision risk (2023)

Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose

Moderate

FDANov 3, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Medical Drainage Bag (Remington) – label date error (2023)

There is an error with the "Use by Date" and "Date of Manufacturer" on the box label.

Low

FDANov 3, 2023FL, PA• Remington Medical, Inc.

Sterile Betadine (Medline) – non-sterile contents (2023)

The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.

High

FDANov 3, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

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