Date Issued: July 3, 2012 Medical and Surgical Specialties: General Surgery, Surgical Technology, and any specialty that uses devices that must be sterilized at low temperatures Device: The Sterrad Cyclesure 24 Biological Indicator, manufactured by Advanced Sterilization Products (ASP), is a product used periodically to monitor and confirm the microbicidal effectiveness of the … [Read more...]
FDA ENTERS CONSENT DECREE WITH H AND P INDUSTRIES (TRIAD GROUP)
TRIAD GROUP MUST AWAIT AN ACCEPTABLE QUALITY ASSURANCE AND QUALITY CONTROL PROGRAM BEFORE RESUMING MANUFACTURING AND DISTRIBUTION Comment The FDA entered into a Consent Decree of Condemnation, Forfeiture and Permanent Injunction against H&P Industries that would prevent them from manufacturing and distributing products from their Hartland, WI facility. Under the decree, … [Read more...]
