A medical device is any piece of equipment instrument designed to diagnose or treat a medical condition. Every month, several medical devices are recalled by the American Food and Drug administration because of the potential to cause harm.
This is a list of recent Class I recalls. Class I recalls are the most serious type of FDA recall and involve situations in which there is a reasonable probability that use of the recalled product will cause adverse health effects or wrongful death.
List of 2010 FDA Medical Device Recalls (April-July)
07/20/10 Alcon Research LTD doing business as Alcon Laboratories, Inc. - CONSTELLATION Vision System: Software and hardware problems have been identified which may cause an unexpected system loss of power (shutdowns), unintended system error messages, unresponsive touchscreens, and system setting and infusion performance problems. These events may cause eye injuries, including blindness.
07/15/10 Symbiq One-Channel Infuser and Symbiq Two-Channel Infuser: The device may fail to detect air in line at the end of an infusion.
07/02/10 Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System: The test may provide false negative MRSA results when compared to MRSA positive results received from culture methods. This could result in incorrect treatment or delay of care for patients with MRSA infection and may lead to MRSA death.
07/02/10 Physio-Control Inc., LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors: A failure on the power supply assembly can result in messages of either "No DC power" or "No DC or AC power". A failure of DC (battery) power can result in the inability to deliver defibrillation therapy in emergency situations if the device will not turn on using DC (battery) power and no AC (line) power is available.
06/14/10 Defibtech LLC, DBP-2800 Battery Pack for ReviveR AED™ and Lifeline AED® Semi-automatic External Defibrillators: When the AED is used with an affected battery pack, the AED may falsely detect an error condition, cancel its charge and not provideneeded therapy.
06/10/10 Counterfeit Polypropylene Surgical Mesh Products Marketed as C. R. Bard/Davol: Counterfeit product does not meet the manufacturer's specifications. In addition, there were discrepancies in the expiration dates.
05/17/10 GE Healthcare Aisys and Avance Anesthesia Systems: Certain GE Healthcare Aisys and Avance machines control board wiring harnesses have a defect that can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring.
05/17/10 Certain Cuffed Shiley Tracheostomy Tubes: The device may leak air, resulting in inadequate ventilation. This could result in a sudden decrease in the amount of oxygen in the blood or a sudden increase in the amount of carbon dioxide in the blood, especially in cases where the patient requires assisted mechanical ventilation. This may result in serious injury, including death.
04/30/10 Cardiac Science Corporation, Powerheart, CardioVive, Nihon Kohden, and GE Responder Automated External Defibrillators (AEDs): Certain models of Powerheart G3 AEDs may not have received adequate electrical
safety testing prior to being shipped from the factory.
04/22/10 Physio-Control Inc., LIFEPAK 15 Monitor/Defibrillator: There is a potential for the device to unexpectedly power Off then On by itself, power Off then NOT turn On, power Off by itself requiring the operator to turn it back On, or to stay powered On and not allow itself to be turned Off. This can lead to a patient not being recussitated.
04/08/10 Teleflex Incorporated - Arrow International Custom Intravenous (IV) Administration Products (IV Tubing Sets and Accessories) and Certain Arrow Arterial Embolectomy Catheters: Internal testing by Teleflex revealed pin holes or punctures in the sterile Tyvek packaging. Because of these defects, the products may no longer be sterile. This may potentially cause blood-borne or other types of infections, which could result in serious injury or death.
Learn more about recent Class I Recalls in the following articles:
2010 FDA Dangerous Medical Device Recalls: Part 1 - If You Were Injured By Any Of These Devices, You May Have a Kansas City Personal Injury Claim
2010 FDA Dangerous Medical Device Recalls: Part 2 - If You Were Injured By A Recalled Medical Device, You May Be Eligible For Compensation. Learn More.
Have You Or A Loved One Been Injured By A Defective Medical Device?
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