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Bard Recalls RapidFire Multiple Band Ligator; A&A Class I Recall Updated

This article was originally published in The Gray Sheet

Executive Summary

CR Bard is recalling 12,206 units of its RapidFire Multiple Band Ligator following discovery that the device may fail to deploy and prevent control of bleeding

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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...

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...

Zoll M Series AED Class I Recall To Be Complete By End Of Second Quarter

Zoll Medical reports that a worldwide recall of M Series biphasic automated external defibrillators is now 80% complete. Initiated in December 2001, the Class I recall appears in FDA's April 24 weekly enforcement report

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