Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall- Device may not be able to deliver therapy during a cardiac resuscitation attempt

Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall

Audience: Emergency medical professionals, hospital risk managers

Cardiac Science Corporation and FDA notified healthcare professionals and consumers of a recall because the automated external defibrillator (AED) may not be able to deliver therapy during a cardiac resuscitation attempt, which may lead to serious adverse events or death. These AEDs were manufactured in a way that makes them potentially susceptible to failure under certain conditions. Each of the approximately 12,200 devices affected in this recall can be confirmed at the Cardiac Science Web site, www.cardiacscience.com/AED195. The affected AEDs were manufactured or serviced between October 19, 2009 and January 15, 2010 and include the following models - Powerheart 9300A, 9300E, 9300P, 9390A, 9390E, CardioVive 92532 and CardioLife 9200G and 9231. Each affected AED should immediately be removed from service since it may not deliver the expected therapy.

Read the complete MedWatch 2010 Safety summary, including a link to the firm press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm200138.htm

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BD Q-Syte Luer Access Devices: Recall-Device may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death

BD Q-Syte Luer Access Devices: Recall

BD Q-Syte Luer Access Devices
BD Nexiva Closed IV Catheter Systems
Acacia IV Extension Sets with BD Q-Syte Luer Access Device

Audience: Hospital risk managers, nursing services managers 

BD, Acacia Inc. (known as MPS Acacia), and FDA notified healthcare professionals of the recall of certain lots of  these devices. The BD Q-Syte Luer Access Device is a needleless valve manufactured by BD, intended for use with other infusion therapy products in the administration of fluids into the intravenous system. Use of the recalled devices may cause an air embolism or leakage of blood or therapeutic product which may result in serious injury or death. The REF/catalog and lot numbers which were sold in the US are noted in the firm's press release. The affected lots were distributed from November 2008 through November 2009.

Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178].

Read the complete MedWatch 2010 Safety summary, including links to both firm's press releases, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm200137.htm

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