This is a list of recent Class 1 recalls. Class 1 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 (March)
03/30/10 Becton, Dickinson (BD) and Company, Q-Syte Luer Access Split Septum and Numerous Products Containing the Q-Syte Luer Access Split Septum Repackaged and Distributed by Acacia Inc. (also known as MPS Acacia), Medical Action Industries, Inc., and Arrow International, Inc.: Four Class I recalls were issued for defects which may result in air bubbles leaking into the infusion system and into the patient’s bloodstream, resulting in an air embolism. In addition, these defective devices may result in leakage of the therapy being infused and result in incomplete and inadequate administration of therapy. There is also a potential for blood leakage through this defect. These problems may result in serious injuries or death .
03/17/10 Gyrus ACMI, Inc. Micron Bobbin Vent Tube T, 1.27 mm: Some units were shipped without being sterilized.
3/11/10 Baylis Medical Company Inc., Torflex Transseptal Guiding Sheath: When used during heart procedures, the sheath tip may break off and separate while the sheath is in the blood vessels. If this occurs, the fragment could move through the heart and arteries to vital organs. This could cause a blockage anywhere in the body, including the brain or heart and may lead to unplanned open heart surgery, permanent injury, such as a stroke or heart attack, and/or death.
03/10/10 Beckman Coulter Inc., UniCel DxC Synchron Clinical System - Ion Selective Electrode (ISE) Flow Cell: There may be excessive build-up of protein, bacteria, and sample tube additives in the instrument’s ion selective electrode flow cell which may cause incorrect sodium results.
03/10/10 Abiomed, Inc., AB5000 Circulatory Support System: The computer in this device may shut down (and stop pumping) without sounding an alarm. This defect may cause serious injuries or death.
03/08/10 Cardiac Science Corporation - Powerheart, Cardiovive, NK, and Responder Automated External Defibrillators (AEDs): The external AEDs were recalled because of defects in certain electronic components that may not be detected by the device’s Daily/Weekly/Monthly self-tests. Because of these defects, the devices may not deliver therapy or may cause improper functioning of the device during a rescue attempt, which may prevent resuscitation. This can lead to serious adverse health events and/or death.
03/08/10 Thomas Medical Products Inc., Transseptal Sheath Introducer Kits: When used during heart procedures, the sheath tip may break off and separate while the sheath is in the blood vessels. If this occurs, the fragment could move through the heart and arteries to vital organs. This could cause a blockage anywhere in the body, including the brain or heart and may lead to unplanned open heart surgery, permanent injury, such as a stroke or heart attack, and/or death.
03/03/10 Baxter HomeChoice and HomeChoice PRO: The recall was issued after reports of serious injuries and at least one death associated with increased Intraperitoneal Volume (IIPV). IIPV is also known as overfill of the abdominal cavity and can cause serious breathing and heart problems that can lead to serious injury or death.
Have You Or A Loved One Been Injured By A Defective Medical Device?
If you or a loved one has been injured by a defective medical device you need to speak with an experienced defective medical device attorney as soon as possible. Please contact us online or call our Kansas City office directly at 816.471.5111 to schedule your free consultation.