Kugel Mesh Hernia Patch Recall Lawsuits Manufacturing Plant Receives FDA Warning Letter

Kugel Mesh Hernia Patch Recall Lawsuits
A Puerto Rican medical device manufacturing plant has received an FDA warning letter concerning its operating procedures. The plant, which manufacturers medical devices such as the Kugel Mesh hernia patch and the Vacora Biopsy Probe, was inspected by the FDA from November 2007 through February 2008. The Kugel Mesh hernia patch manufactured by Bard has been recalled due to defects in the memory recoil ring. This latest warning letter from the FDA spells more problems for C.R. Bard, Inc.
Kugel Mesh Hernia Patch Recall Lawsuits
The 11-page FDA warning letter cites numerous complaints concerning operating procedures at the plant. The FDA inspectors called the medical devices “adulterated” becuase “the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations, Part 820.”
The 11-page report specifically cites 8 complaints in particular but notes that these are not an exhaustive list of the defects concerning the plant. Here is the FDA’s summary of the 8 named complaints:
1)Failure to establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation
2)Failure to establish and maintain procedures to control product that does not conform to specified requirements
3)Failure to identify the action(s) needed to correct and prevent the recurrence of nonconforming product and other quality issues. In addition, procedures addressing the identification of corrective and preventative actions were not implemented
4)Failure to implement and record changes in methods and procedures needed to correct and prevent identified quality problems as required
5)Failure to retain all required records for a period of time equivalent to the design and expected life of the device, but in no case less than two years from the date of release for commercial distribution by the manufacturer as required
6)Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints. In addition, failure to process all complaints in a uniform and timely manner
7)Failure to conduct quality audits in a timely manner to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system as required
8)Management with executive responsibility has failed to ensure that an adequate and effective quality system has been fully implemented and maintained at all levels of your organization as required
These 8 complaints, while not exhaustive, is a stinging indictment of operational procedures at the Puerto Rican plant that makes the defective Kugel Mesh hernia patch. The hernia patch maker has already come under fire from the FDA for not revealing quality issues in a timely fashion as well as not taking proper safety steps to correct medical device defects. This latest problem only adds to the Kugel Mesh hernia patch defect story.
Kugel Mesh Hernia Patch Recall Lawsuits