| Subject: | FDA Warns of Possible Misbranding of Reusable Devices Labeled for Reprocessing by the STERIS System 1 Processor |
| Category: | Food and Drug Administration (FDA)
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| Published: | Mon, 22 Feb 2010 - 12:00 pm |
| The Food and Drug Administration (FDA) has sent a letter advising healthcare facilities of possible misbranding of reusable devices labeled for reprocessing by the STERIS System 1 Processor. Background In a notice dated December 3, 2009, the FDA informed healthcare facilities that STERIS Corporation has significantly modified the SS1 and that FDA has not approved or cleared this modified product. Thus, FDA has not determined that the SS1 is safe or effective for its labeled claims,... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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