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 (October, November)
11/12/10 SIGMA Spectrum Infusion Pump Model 35700: The recalled units may fail suddenly causing inaccurate flow conditions during use. These range from back flow to over-infusion, including free flow, which could result in serious injury or death. The pump does not issue an alarm when this occurs.
11/10/10 bioMérieux, Inc., VITEK 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam (TZP): This medical test is reporting incorrect results for testing the susceptibility of E. coli and K. pneumoniae to Piperacillin/Tazobactam (TZP). Incorrect results could potentially lead to patients being inappropriately treated with Piperacillin/Tazobactam, which could cause serious injury or death.
11/04/10 Hospira Symbiq One and Two Channel Infuser: Motor encoder failures in the Symbiq pumping mechanism may cause the infuser to cease operation and exhibit an audible and visual “S321” or “S421” alarm in the One and Two-Channel infusers. Delay or interruption of therapy may result in serious injury or death in patients receiving critical therapy, pediatric patients, and neonates.
11/02/10 Medtronic Octopus Nuvo Tissue Stabilizer, Model TSMICS1: A component of the device has the potential to fracture during use. Fragments of the component could fall into the patient’s chest cavity and/or damage the heart tissue leading to serious injury or death.
10/26/10 Excelsior Medical Disposable Syringe with Normal Saline (0.9% Sodium Chloride, 5mL fill in 6mL syringe): These syringes may leak and lose sterility. The loss of sterility may result in an infection in the bloodstream which could cause serious injury or death.
10/15/10 CareFusion Corporation, Alaris PC Units (Model 8015): Certain wireless network conditions may cause a communication error to occur. The error will freeze the PC Unit screen and may result in a delay of therapy and an inability to make necessary programming changes to current infusions. A communication error during infusion could cause the PC unit to shut down resulting in a delay or interruption in therapy that may lead to serious injury and/or death.
10/13/10 Westmed Inc., BagEasy Manual Resuscitation Devices: There is a potential of a disconnection at the patient port retention ring assembly. If such a disconnection occurs, the device will not work. This may result in life-threatening treatment delays.
10/12/10 Multi-Med, Inc. Huber (Non-coring) Needles and Finished Devices Containing Huber Needles Labeled as "All-Med Medical Products, Inc." and "Marquette Medical, Inc." Brands and Provided to Some Consignees in Bulk without Labeling: This is an expansion of a previous recall and now includes all devices with Huber needles. Needles may “core”. If "coring" occurs, the Huber needle could damage the implanted port by removing silicone slivers from the access membrane. The damage to the port can cause the ports to leak. The core may enter a patient’s body when the port is initially accessed if it is not flushed correctly. These issues may lead to the decreased effectiveness of the port, replacement of the port, infection, damage or death of tissue, swelling, or other serious adverse health consequences as the core travels through blood vessels into the patient’s lungs or other organs. These issues may potentially cause death.
For more information about recalled medical devices, read:
2010 FDA Dangerous Medical Device Recalls: Part 4 - If You Were Injured By A Recalled Medical Device, You Have Important Legal Rights. Learn More.
Companies that manufacture medical devices are responsible for ensuring the safety and effectiveness of their products before marketing them. If you or a loved one sustained injury from a recalled medical device, you may be entitled to compensation for your medical expenses, lost wages and other losses. To learn more contact Kansas City Accident Injury Attorneys at 888-348-2616 to schedule a free case evaluation with a Kansas City defective medical device attorney.
For more information about Kansas City personal injury claims, download a copy of our free book, “10 Essential Steps You Must Take To Protect Your Injury Claim.”