FDA issues letter on KARL STORZ recall of urological endoscopes
On April 4, the U.S. Food and Drug Administration (FDA) issued a letter to healthcare providers to make them aware of a voluntary recall initiated by manufacturer KARL STORZ for certain urological endoscopes.
“As the FDA continues to evaluate the risk of patient infections and contamination issues associated with reprocessed urological endoscopes, the FDA is aware that the current reprocessing instructions for certain urological endoscopes manufactured by KARL STORZ are inadequate and are being updated by KARL STORZ,” the letter reads. “The affected urological endoscopes include cystoscopes, ureteroscopes, cystourethroscopes and ureterorenoscopes, used for viewing and accessing the urinary tract.”
The letter further states that on April 1, KARL STORTZ initiated the recall and issued an urgent field safety notice “to instruct users to discontinue all high-level disinfection methods for all affected urological endoscopes and discontinue liquid chemical sterilization for most of the affected urological endoscopes.”
“The affected urological endoscopes should be sterilized after each use by an appropriate sterilization method recommended in the instructions for use,” the letter reads.
Read the FDA letter to see its recommendations regarding this issue.