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Tuesday, January 5, 2010
Class 1 recall of the Trailblazer Support Catheter
On January 5, 2010, The FDA issued a MedWatch safety and information report including information about a Class 1 recall of the Trailblazer Support Catheter device.
The recalled catheter is a medical device used to help with the delivery of solutions in the veins or arteries for the treatment of patients.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Specifically, this device may crack near the radiopaque marker band which may result in serious patient injury, including insufficient oxygen supply to the tissues, damage to blood vessels, heart attack, limb amputation, unplanned surgery, and/or death.
Ev3 Endovascular, Inc., has sent a letter to all of its consumers summarizing the problem with the device and requesting the product be returned to their company.
Model Numbers recalled include: SC-014-135, SC-018-090, SC-035-065, SC-035-135, SC-014-150, SC-018-150, SC-035-090, SC-035-150.
The recalled catheter is a medical device used to help with the delivery of solutions in the veins or arteries for the treatment of patients.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Specifically, this device may crack near the radiopaque marker band which may result in serious patient injury, including insufficient oxygen supply to the tissues, damage to blood vessels, heart attack, limb amputation, unplanned surgery, and/or death.
Ev3 Endovascular, Inc., has sent a letter to all of its consumers summarizing the problem with the device and requesting the product be returned to their company.
Model Numbers recalled include: SC-014-135, SC-018-090, SC-035-065, SC-035-135, SC-014-150, SC-018-150, SC-035-090, SC-035-150.
Labels: Class 1 recall, FDA, MedWatch
posted by
Megan M. McBride
at
12:35 PM
Friday, July 10, 2009
Class I Recall for Respironics' BiPAP Focus Non-Invasive Ventilator System
The FDA yesterday elevated the recall on the BiPAP Focus Non-Invasive Ventilator System to a Class I status. The ventilator, manufactured by Respironics California, Inc., is being recalled for power supply failures. The device is used by healthcare professionals to treat adult patients who have advanced lung disease or difficulty breathing. In the ventilator, a wiring problem may cause a power surge which can exceed the power supply capacity, causing the power supply to lose power and the ventilator to not function properly.
Class I recalls are the most serious type of recall and involve products that the use of can cause serious injury or death. The particular product being recalled is model number PCM120PS18-2315P. Customers or health care providers can contact Respironics Customer Service at 1-877-387-3377.
For more information, see the MedWatch safety information at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171242.htm
See the Recall Notice from the FDA at:
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm171194.htm
Class I recalls are the most serious type of recall and involve products that the use of can cause serious injury or death. The particular product being recalled is model number PCM120PS18-2315P. Customers or health care providers can contact Respironics Customer Service at 1-877-387-3377.
For more information, see the MedWatch safety information at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171242.htm
See the Recall Notice from the FDA at:
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm171194.htm
Labels: Class 1 recall, FDA, Lung disease, Respironics, Ventilator
posted by
Colleen
at
7:35 AM
Sunday, May 24, 2009
Class 1 Recall of Infant Apnea Monitor
Respironics, the manufacturer of the SmartMonitor 2 Infant Apnea Monitor, announced that it has voluntarily recalled 4,992 infant apnea monitors. The device continuously monitors infant respiration and heart rate in the hospital or in the infant's home or in the hospital. The monitor was designed to detect, and sound an alarm for, periods of temporary interruption of breathing (central apnea) or low heart rates. The FDA announced that the Class 1 recall is necessary to protect consumers from serious injury.
Class 1 is the most serious degree of recall, involving a reasonable probability that use of affected products will cause serious injury or death.
This recall applies to SmartMonitor 2 models 4002 and 4003 -- caregivers and/or parents using a SmartMonitor 2 Infant Apnea Monitor for their infant should contact their homecare provider immediately to determine if their device is affected. However, they should continue using the apnea monitor until it is replaced, unless directed otherwise by a physician.
Any adverse reactions experienced with the use of this device should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
Class 1 is the most serious degree of recall, involving a reasonable probability that use of affected products will cause serious injury or death.
This recall applies to SmartMonitor 2 models 4002 and 4003 -- caregivers and/or parents using a SmartMonitor 2 Infant Apnea Monitor for their infant should contact their homecare provider immediately to determine if their device is affected. However, they should continue using the apnea monitor until it is replaced, unless directed otherwise by a physician.
Any adverse reactions experienced with the use of this device should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
Labels: Adverse Events, Class 1 recall, devices, FDA, MedWatch, SmartMonitor
posted by
Megan M. McBride
at
1:11 PM