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Dental Mercury, Amalgam Packaging Should List All Ingredients – FDA

This article was originally published in The Gray Sheet

Executive Summary

FDA is recommending that manufacturers of dental mercury, amalgam alloy and encapsulated amalgam devices list all ingredients to help minimize the risk of allergic reactions to restorative materials

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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

Regulatory News In Brief

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

Regulatory News In Brief

Sleep apnea monitors: Effective Oct. 15, 1sleep apnea monitor final rule creates a separate category for the devices, which are currently classified as frequency breathing monitors. Manufacturers seeking clearance for sleep apnea monitors should demonstrate conformance to the sleep apnea monitor special controls guidance accompanying the July 17 final rule, or prove that the firm has taken equivalent measures to provide reasonable assurance of safety and effectiveness, FDA notes...

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