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