Karl Storz is recalling more than two dozen models of its urological endoscopes over concerns that the devices may not be adequately cleaned using instructions from the manufacturer.
In an "urgent field safety notice" to customers dated April 1, the company said the recall applies to single channel endoscopes – including video instruments and conventional cystoscopes, ureteroscopes, cysto-urethroscopes, and uretero-renoscopes — with an attached T-Luer that are intended to be cleaned by high-level disinfection or liquid chemical sterilization.
The recall comes a year after the US Food and Drug Administration asked Karl Storz to test the safety of the urologic scopes after receiving more than 450 reports of infections, including three deaths, and related problems associated with this class of devices.
Karl Storz said product testing found that these specified cleaning methods did not achieve the "required efficacy level of disinfection" for the devices.
According to Karl Storz, "Customers that do not have access to an appropriate sterilization method recommended in the applicable instructions for use for these endoscopes should discontinue use of the endoscopes and return them" to the company.
Karl Storz said it was in the process of updating the cleaning procedures for the devices and would notify customers of the changes by April 18. "Once the updated instructions for use are available, please discard any prior versions of the instructions for use for the affected endoscopes that you may possess," the company stated.
Customers who have sold any of the affected devices should contact the purchasers to inform them of the recall, the letter added.
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Cite this: Urologic Scopes Recalled OverContamination Fears - Medscape - Apr 04, 2022.