Products marketed as dietary supplements contain undeclared analogue of sildenafil, a drug which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.
Mikro-Tip Angiographic Catheter, Model SPC-454D and SPC-454F by Millar Instruments Inc.: Class 1 RecallApril 1, 2011 4:31 am | by U.S. Food & Drug Administration | News | Comments
Small particles (debris) may be found inside the catheter and potentially travel (embolize) from the catheter to tissues, blood vessels, limbs and organs which can result in serious injury and /or death.
Heartstring II Proximal Seal System (HS-1045) by Maquet Cardiovascular, LLC: Recall - Insufficient AdhesiveApril 1, 2011 4:30 am | by U.S. Food & Drug Administration | News | Comments
The deployment tube may detach during use and may result in the failure of the product to operate, This may cause serious injury and/or death.
The InterStim® Therapy System is a surgically implanted device used to help a patient reduce the number of bowel accidents (fecal incontinence)2. The InterStim® Therapy System has several components: a neurostimulator which delivers an electrical pulse...
Meds IV Pharmacy, IV Compounded Products Recall: Outbreak of Serratia Marcescens Bacteremia in Alabama HospitalsMarch 30, 2011 11:30 am | by U.S. Food & Drug Administration | News | Comments
Use of contaminated products may lead to bacterial infection of the blood.
Products marketed as dietary supplement contain drug ingredients sulfosildenafil or tadalafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.
Soladek Vitamin Solution: Unapproved Product May Contain Dangerously High Levels of Vitamins A and DMarch 29, 2011 4:31 am | by U.S. Food & Drug Administration | News | Comments
Reports of consumers experiencing decreased renal function, elevated levels of calcium in the blood, fatigue, heart arrhythmia, vomiting, and diarrhea.
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test SystemMarch 23, 2011 8:30 am | by U.S. Food & Drug Administration | News | Comments
This document was developed as a special controls guidance to support the classification of ovarian adnexal mass assessment score test system into class II (special controls). An ovarian adnexal mass assessment score test system measures one or more...
The objective of this public meeting is to present the CDRH FY 2010 Priorities. In addition, FDA is interested in engaging in discussions about issues that are of importance to the medical device community. CDRH wishes to obtain feedback/ideas for...
Manufacturers and importers of all devices must continue to submit malfunction reports as they await a promised easing of requirements for Class I devices and Class II devices that are not permanently implantable, life supporting or life sustaining.
Device manufacturers have won a victory in Congress now that the Senate has passed patent-reform legislation that includes several provisions favorable to the industry.
The Food and Drug Administration?s eSubmitter tool is part of an electronic submissions program that originated in the Center for Devices and Radiological Health (CDRH). The eSubmitter program is the result of two successful pilot programs at CDRH named..
FDA Safety Notification: Mammography Problems at Huntington Radiology in Huntington Park, CaliforniaMarch 10, 2011 7:30 am | by U.S. Food & Drug Administration | News | Comments
The FDA became aware of problems associated with the quality of mammograms performed at the Huntington Radiology facility, located at the following address...
New Warning about serious heart, kidney, or breathing problems which can be fatal.
Lynn Peavey, a manufacturer of sexual assault evidence and blood alcohol collection kits, has received a GMP warning for several issues, such as lack of procedures for incoming product inspections and lack of verification activities.
U.S. devicemakers may have difficulty obtaining a virus strain that the FDA suggests using to conduct reactivity tests for new products to detect Clostridium difficile infections.
Topamax (topiramate): Label Change - Risk For Development of Cleft Lip and/or Cleft Palate in NewbornsMarch 4, 2011 7:30 am | by U.S. Food & Drug Administration | News | Comments
Increased risk of oral clefts in infants born to women treated with Topamax (topiramate) during pregnancy.
Endotoxins in product can cause serious illness, at times fatal.
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.
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 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 UseMarch 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).
FDA meta-analysis of clinical trials did not show an increased risk of MI associated with the use of abacavir.
UPDATED 02/28/2011. Reports of deaths and serious complications, especially bleeding and infection, associated with NPWT.