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2,800 Custom Ultrasonics Endoscope Washers Recalled by the FDA

Chelcy Williams11 months ago

The FDA has ordered Ivyland, PA's Custom Ultrasonics to recall all 2,800 of its Automated Endoscope Preprocessors from hospitals and clinics, due to Federal Food, Drug, and Cosmetic Act violations.

FDA Takes Rare Action in Forcing Recall

Unlike many other FDA recalls, this particular recall is not involuntary and as of Nov. 13, Custom Ultasonics has 7 days to provide a written recall proposal to the FDA.

According to a FDA press release, Dr.William Maisel, the chief scientist in the FDA's device arm (CDRH) states, “We are taking action because Custom Ultrasonics failed to meet its legal and regulatory obligations.” 

In a previous safety alert, Custom Ultrasonics took part in a consent decree with the FDA in 2007, but has since failed to maintain their safety standards.

Recently, the FDA has been cracking down on inadequate medical device disinfections following a string patient deaths and hospitalizations due to infections caused by unsterile devices.

Statistics on FDA Medical Device Recalls

The information below was provided by Applied Clinical Trials

  • Between 2008-2011 the number of medical device recalls has increased by 250%
  • The FDA has classified and described over 1,700 distinct types of medical devices and categorize recalls by classes.
  • Medical device recalls due to microbial contamination make up 11% of all device recalls
  • Microbial contaminated devices are the third largest category of recalled items in the medical recall field 

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