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Showing 3321–3340 of 11714 results

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Nipro Renal Soultions USA, Corporation: Citric Complete - Dry Citric Acid Concentrate Model Numbe...

The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.

FDANov 22, 2024AZ, FL, GA +7 more• Nipro Renal Soultions USA, Corporation

Cook Biotech, Inc.: Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-...

Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.

FDANov 22, 2024IN, MI• Cook Biotech, Inc.

Cook Biotech, Inc.: Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X1...

Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.

FDANov 22, 2024IN, MI• Cook Biotech, Inc.

Cook Biotech, Inc.: Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G...

Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.

FDANov 22, 2024IN, MI• Cook Biotech, Inc.

Technetium Tc 99m Sulfur Colloid Kit (Jubilant Radiopharma) – Stability Failure (2024)

Failed Stability Specifications

FDANov 22, 2024Nationwide• Jubilant Draximage Inc., dba Jubilant Radiopharma

Javygtor Tablets 100mg (Dr. Reddy's) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications

FDANov 22, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Irregular Pigmentation Accelerator (Generitech) – Water System Inconsistency (2024)

CGMP Deviations: Inconsistency in the water systems.

FDANov 22, 2024CA• Generitech Corporation

Dihydroergotamine Mesylate Injection (Provepharm Inc.) – Discoloration (2024)

Discoloration

FDANov 22, 2024Nationwide• Provepharm Inc.

VCF Contraceptive Gel (Apothecus) – Assay Deviation (2024)

CGMP deviations: out of specifications for assay

FDANov 22, 2024Nationwide• Apothecus Pharmaceutical Corp.

GE OEC Medical Systems, Inc: OEC 3D REF Image-Intensified Fluoroscopic X-Ray System,...

Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.

FDANov 21, 2024AK, AZ, CA +41 more• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: OEC Elite REF Image-Intensified Fluoroscopic X-Ray Syst...

Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.

FDANov 21, 2024AK, AZ, CA +41 more• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: OEC 9900 REF Image-Intensified Fluoroscopic X-Ray Syste...

Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.

FDANov 21, 2024AK, AZ, CA +41 more• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: OEC 9800 REF Image-Intensified Fluoroscopic X-Ray Syste...

Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.

FDANov 21, 2024AK, AZ, CA +41 more• GE OEC Medical Systems, Inc

Abbott Medical: The Merlin PCS 3650 programmer Model 3330 The Merlin PCS...

Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail. If this occurs, the Programmer displays a loss of telemetry detected window, and there is no pacing.

FDANov 21, 2024Nationwide• Abbott Medical

Medtronic Neuromodulation: SynchroMed II Model 8637 and SynchroMed III Model 8667 im...

Software issues were identified in application version 2.x.

FDANov 21, 2024Nationwide• Medtronic Neuromodulation

MEDLINE INDUSTRIES, LP Northfield: Medline custom medical procedure kits labeled as: 1) C...

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

FDANov 21, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

MEDLINE INDUSTRIES, LP Northfield: See DocMan

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

FDANov 21, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

Nova Biomedical Corporation: StatStrip Glucose Hospital Meter System. Model/Catalog Nu...

A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current glucose test result to the DMS. The risk of this software defect is erroneously high or low glucose results being documented in a patient's medical record, which may lead to incorrect treatment.

FDANov 20, 2024Nationwide• Nova Biomedical Corporation

Nova Biomedical Corporation: StatStrip Glucose Ketone Hospital Meter System. Model/Cat...

A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current test result to the DMS.

FDANov 20, 2024Nationwide• Nova Biomedical Corporation

Nova Biomedical Corporation: StatStrip Glucose Ketone (mmol/L) Hospital Meter System. ...

A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current test result to the DMS.

FDANov 20, 2024Nationwide• Nova Biomedical Corporation

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