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Davol XenMatrix Surgical Graft: Class I Recall - Elevated Endotoxin Levels(2)

March 4, 2011 5:31 am | by U.S. Food & Drug Administration | News | Comments

Endotoxins in product can cause serious illness, at times fatal.

Class I Medical Device Recall: Davol Inc., XenMatrix Surgical Graft

March 4, 2011 4:30 am | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: Testing cannot confirm that all units of XenMatrix Surgical Graft are within FDA requirements for endotoxin levels. Several lots have been found to have elevated endotoxin levels. Endotoxins (pyrogens) are substances found in certain...

Cook Inc., Single, Double, Triple and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripheral Inserted Central Venous Catheter Trays: Class I Reca...

March 3, 2011 12:31 pm | by U.S. Food & Drug Administration | News | Comments

Leakage and possible loss of sterility, which may lead to serious adverse health consequences and/or death.

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Class I Medical Device Recall: Cook Inc., Single, Double, Triple and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripheral Inserted Central Veno...

March 3, 2011 10:30 am | by U.S. Food & Drug Administration | News | Comments

These kits and trays contain 0.9% Sodium Chloride Injection USP 5 mL fill in 6 mL flush syringes that have been recalled by Excelsior Medical. Leaks in the plunger luer were detected during a routine syringe leak test. The potential exists for leakage...

Unapproved Cough, Cold, Allergy Products: FDA Prompts Removal From Market

March 2, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

Unapproved products have not been evaluated by the FDA for safety, effectiveness, and quality.

Proton Pump Inhibitor drugs (PPIs): Drug Safety Communication - Low Magnesium Levels Can Be Associated With Long-Term Use

March 2, 2011 5:30 am | by U.S. Food & Drug Administration | News | Comments

Prolonged treatment with prescription PPIs may lead to low serum magnesium levels, which can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures).

Abacavir - Ongoing Safety Review: Possible Increased Risk of Heart Attack

March 1, 2011 9:30 am | by U.S. Food & Drug Administration | News | Comments

FDA meta-analysis of clinical trials did not show an increased risk of MI associated with the use of abacavir.

Negative Pressure Wound Therapy (NPWT) systems - Preliminary Public Health Notification

February 28, 2011 3:30 am | by U.S. Food & Drug Administration | News | Comments

UPDATED 02/28/2011. Reports of deaths and serious complications, especially bleeding and infection, associated with NPWT.

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Svelte 30: Recall - Undeclared Drug Ingredient

February 25, 2011 1:32 pm | by U.S. Food & Drug Administration | News | Comments

Product marketed as a dietary supplement contains sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

EU Patent System Moves Forward But Still Facing Difficulties

February 25, 2011 1:32 pm | by U.S. Food & Drug Administration | News | Comments

With the European Parliament’s consent for enhanced cooperation, a common EU patent system may become a reality.

Medtronic Is Cutting Staff, Selling Unit, in & #8216;Soft & #8217; Times

February 25, 2011 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Medtronic is eliminating up to 2,000 positions during the third quarter as part of a major restructuring it blames on softer markets.

Consumer Information on: Revo MRI SureScan Pacing System - P090013

February 24, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

The Revo MRI SureScan Pacing System is designed to deliver standard pacing therapy in patients who have slow heart rates (bradycardia). Unlike most other pacing systems, the Revo MRI SureScan Pacing System has been specifically designed and tested to...

Summary Information for: Revo MRI SureScan Pacing System

February 24, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for Revo MRI SureScan Pacing System (P090013).

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Extenze Tablets: Recall

February 23, 2011 10:31 am | by U.S. Food & Drug Administration | News | Comments

Counterfeit dietary supplement contains tadalafil, sildenafil, and/or sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

Medical Device Safety Tip: Infant Phototherapy Light

February 23, 2011 5:30 am | by U.S. Food & Drug Administration | News | Comments

FDA received a report about a brown area on the lens cover of an infant phototherapy light. Upon closer examination, the lens cover also had burned and melted areas from having been improperly positioned under the heating element of an infant warmer...

Antipsychotic drugs: Class Labeling Change - Treatment During Pregnancy and Potential Risk to Newborns

February 22, 2011 6:32 am | by U.S. Food & Drug Administration | News | Comments

Risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs.

FDA Down-Classifies MDDS to Class I Via Final Rule

February 18, 2011 7:30 pm | by U.S. Food & Drug Administration | News | Comments

The FDA has down-classified medical device data systems (MDDS) from Class III into Class I via a final rule, which could help manufacturers compete with IT companies in this area.

FDA Questions UK Regulator & #8217;s Data on Hip Implant Recalls(2)

February 18, 2011 5:31 pm | by U.S. Food & Drug Administration | News | Comments

Quality problems with metal-on-metal (MoM) hip replacement systems, like Johnson & Johnson (J&J)’s ASR devices, may not be as widespread as UK data indicates, the FDA says.

Terbutaline: Label Change - Warnings Against Use for Treatment of Preterm Labor

February 17, 2011 8:31 am | by U.S. Food & Drug Administration | News | Comments

Potential for serious maternal heart problems and death.

Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits: Class 1 Recall

February 16, 2011 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Recall due to pocket fills may result in patient harm, serious injury, and/or death due to drug overdose or underdose.

Class I Medical Device Recall: Abbott Glucose Test Strips

February 15, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

These test strips may give falsely low glucose results. False results may lead patients or health care providers to try to raise their blood glucose unnecessarily, or they may fail to treat elevated blood glucose because of a false, low reading...

Class II Medical Device Recall: Triad Group, Triad Sterile Lubricating Jelly

February 15, 2011 4:30 am | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: This product may not be sterile. Patients, who are immuno-compromised, such as those with diabetes, cancer and certain other chronic diseases, may be at potential risk for infection.

FDA Finalizes Regulation for Certain Software, Hardware Used With Medical Devices

February 14, 2011 10:30 am | by U.S. Food & Drug Administration | News | Comments

Today, the FDA announced a final rule that provides a less-burdensome path to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or...

Tra Warning Letter Cites Lack of GMP Procedures, Controls

February 11, 2011 2:31 pm | by U.S. Food & Drug Administration | News | Comments

An FDA inspection of Tra & Accessories found failures in its control of design, purchasing and the warehouse environment for products, resulting in a warning letter.

Breast Implant Panel Requested, FDA Oversight Questioned

February 11, 2011 2:30 pm | by U.S. Food & Drug Administration | News | Comments

Rep. Rosa DeLauro (D-Conn.) is “strongly urging” CDRH to hold an advisory committee meeting to release all available information on 10-year postmarket study results for saline breast implants and address issues with FDA oversight of the trials.

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