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Showing 4881–4900 of 11714 results

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Sirolimus Tablets (Dr. Reddy's) – Impurity Specification Failure (2024)

Failed Impurities/Degradation Specifications

Class IIILow

FDAMay 1, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Magnesium Citrate (Pharma Nobis) – Bacterial Contamination (2024)

Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria

Class IIModerate

FDAMay 1, 2024Nationwide• Pharma Nobis LLC

Magnesium Citrate (Pharma Nobis) – Bacterial Contamination (2024)

Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria

Class IIModerate

FDAMay 1, 2024Nationwide• Pharma Nobis LLC

TabloCart (Outset Medical) – Cord Connector Defect (2024)

A cart with prefiltration drawer, an optional hemodialysis system accessory, has a cord with a female connector that has internal contact pins that may become damaged that could create localized heat, sparks, smoke, melting or charring (thermal event) of the female connector or the associated connector power entry module, which may lead to transient delay in treatment or blistering to the user.

High

FDAApr 30, 2024Nationwide• Outset Medical, Inc.

Agilis NxT Steerable Introducer (St. Jude) – Short Dilators (2024)

One lot of product has dilators that are too short and will not extend outside the introducer sheath.

Moderate

FDAApr 30, 2024Nationwide• St. Jude Medical

ZOLL 731 Ventilator (ZOLL) – MRI Safety Information (2024)

Operator's Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Patient Safety Ventilator MRI information omitted from the manuals. Update to the instructions ensures safe distance from the MRI to ensure proper function of the ventilator and reduce the risk of delay in ventilator therapy

Low

FDAApr 30, 2024Nationwide• ZOLL Medical Corporation

Medline Iris Scissors (Medline) – Tip Protector Issue (2024)

There is the potential of the tip protector to fall off 4.5" sterile, curved, Iris Scissors

Low

FDAApr 30, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

FiberOptix IAB Catheter Kit (Arrow) – Health Consequence (2024)

Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.

High

FDAApr 29, 2024Nationwide• ARROW INTERNATIONAL Inc.

BSM-3000 Bedside Monitor (Nihon Kohden) – SpO2 Alarm (2024)

Due to software issue the device may give false "SpO2 Probe Failure" alarm

Moderate

FDAApr 29, 2024Nationwide• Nihon Kohden America Inc

UltraFlex IAB Catheter Kit (Arrow) – Health Consequence (2024)

High

FDAApr 29, 2024Nationwide• ARROW INTERNATIONAL Inc.

Ultra 8 IAB Catheter Kit (Arrow) – Health Consequence (2024)

High

FDAApr 29, 2024Nationwide• ARROW INTERNATIONAL Inc.

GlideScope Core Monitor (Verathon) – Image Display (2024)

Due to software issues, their is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices.

Low

FDAApr 29, 2024AL, AK, AZ +46 more• Verathon, Inc.

Decompression Table (Pivotal Health) – Frame Part Issue (2024)

This product is being recalled due to potentially insufficient rework on a part (E7130-B) on the lumbar section of the frame on 6 distributed tables. There were 4 additional tables with the faulty E7130-B part that were manufactured, but had not been distributed yet.

Low

FDAApr 29, 2024CA, FL, GA +3 more• Pivotal Health Solutions, Inc.

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Class IIModerate

FDAApr 29, 2024Nationwide• Breckenridge Pharmaceutical, Inc

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Class IIModerate

FDAApr 29, 2024Nationwide• Breckenridge Pharmaceutical, Inc

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Class IIModerate

FDAApr 29, 2024Nationwide• Breckenridge Pharmaceutical, Inc

H-E-B Creamy Creations Chocolate Ice Cream (H-E-B) – Metal Contamination (2024)

Potential metal contamination

Class IIModerate

FDAApr 27, 2024TX• H-E-B San Antonio Retail Support Center (SARSC)

H-E-B Creamy Creations Homemade Ice Cream (H-E-B) – Metal Contamination (2024)

Potential metal contamination

Class IIModerate

FDAApr 27, 2024TX• H-E-B San Antonio Retail Support Center (SARSC)

H-E-B Creamy Creations Lime/Orange Ice Cream (H-E-B) – Metal Contamination (2024)

Potential metal contamination

Class IIModerate

FDAApr 27, 2024TX• H-E-B San Antonio Retail Support Center (SARSC)

O-arm O2 Imaging System (Medtronic) – Electrical Component (2024)

Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional imaging, cancellation and rescheduling of surgery, or completion of surgery without the benefit of image guidance.

High

FDAApr 26, 2024Nationwide• Medtronic Navigation, Inc.-Littleton

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