Medical Equipment Manufacturer C.R. Bard Receives FDA Warning Letter

hospital operating room

C.R. Bard, a prominent New Jersey manufacturer of medical equipment, has recently received a warning letter from the Food and Drug Administration for allegedly failing to properly file customer complaints related to their Recovery Cone Removal System, including a report of a patient death related to use of the device, as well as for failing to inform the FDA of major changes made to their device before they proceeded with manufacture. The Recovery Cone Removal System is used to remove inferior vena cava filters, which are used to capture blood clots that form in the legs before they reach the lungs or heart.

According to the FDA, C.R. Bard has also struggled in recent years to meet the following requirements:

  • Conduct audits in a timely manner
  • Establish procedures for reviewing customer complaints
  • Retain records
  • Make changes to their product to correct quality problems
  • Create and maintain procedures to handle product that does not meet the quality requirements

The FDA alleges that the Recovery Cone Removal System device was manufactured without receiving clearance or approval, and so far has not received adequate responses to the violations from C.R. Bard. Until these issues, which affect multiple facilities, are addressed, the FDA will not approve any further premarket submissions of certain unapproved Class III medical devices.

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The FDA exists to protect our safety. While they do what they can to enforce safety rules and regulations, a small number of unsafe products may slip through the cracks before violations can be corrected.

If you or a loved one have been injured due to a defective medical product, know that you don’t have to shoulder the burden of paying for an injury that you should never have received in the first place. Contact the Atlanta personal injury lawyers at Schneider Hammers as soon as possible to begin building a case that may bring you compensation for your medical care, pain and suffering, lost wages, and more.

Get started by calling us at (770) 884-4626 or by filling out an online form for your free case evaluation.

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