Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Abbott catheter recall: Abbott is recalling four lots of Powersail coronary dilation catheters--three from U.S. distribution and one from international distribution--following four complaints of damage to the distal shaft of the catheter, firm announced July 28. FDA is classifying the recall as Class I, the most serious category, according to the firm. The observed damage could cause the contrast material to leak, potentially causing clinical problems such as air embolism or myocardial infarction, Abbott says. Sales reps have instructed all customers to stop using the affected lots. Patients already successfully treated with Powersail coronary catheters are not affected by the recall
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Regulatory News In Brief
Fiscal 2012 budget cuts: White House Office of Management and Budget Director Peter Orszag and White House Chief of Staff Rahm Emanuel are directing federal agencies to find ways to cut their fiscal 2012 budgets by 5%, according to a June 8 1memo and budget 2guidance. Agencies should identify programs "that have the lowest impact on your agency's mission," the memo states. Fiscal 2012 budget submissions are due to OMB by Sept. 13. The Obama administration has pledged to freeze non-security discretionary spending through fiscal 2013