According to the Food and Drug Administration, doctors and hospitals should stop using a device from Steris Corp. to sterilize surgical tools after receiving several reports of malfunction.
The SS1 sterilizer device has not been cleared as safe and effective after being modified by the company.
Problems have been reported by the users which could result in patients becoming infected from non-sterile instruments as per a statement by the FDA released later this Thursday.
Physicians have been recommended by the FDA to start using alternative devices as soon as possible.
Steris shares plummeted $4.17 or 122.5 percent to close at $29.14 on Friday. The company did not return a call for any comment.
FDA officials told reporters Friday that they are "considering all available options," against Steris, but did not elaborate on a specific actions.
"FDA is not satisfied that the firm has been working effectively to transition its customers," the agency said. Steris representatives have been "reassuring customers that there is no need for a change in their clinical practice."
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