LifeScan, Inc. is recalling eight lots of OneTouch ® SureStep ® Test Strips, used by people with diabetes to measure their blood glucose levels at home. The test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL. The eight lots of consumer OneTouch SureStep Test Strips … [Read more...]

Acacia, Inc. (formally known as MPS Acacia) has voluntarily executed a product recall of certain lots of IV Extension Sets with BD Q-Syte™ Luer Access Device. The BD Q-Syte™ Luer Access Device is a Needleless Valve manufactured by BD (Becton, Dickinson and Company). Use of the affected BD Q-Syte™ Luer Access Device may cause an air embolism or … [Read more...]

Cardiac Science Corporation [NASDAQ: CSCX] is initiating a worldwide voluntary recall after determining that approximately 12,200 automated external defibrillators (AEDs) may not be able to deliver therapy during a resuscitation attempt, which may lead to serious adverse events or death. These AEDs were manufactured in a way that makes them … [Read more...]

Becton, Dickinson and Company is recalling certain lots of BD Q-Syte ™ Luer Access Devices and BD Nexiva ™ Closed IV Catheter Systems. Use of the affected devices may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death. This field corrective action included notification to customers worldwide by … [Read more...]

FDA and Edwards Lifesciences notified healthcare professionals of a Class I recall of the Aquarius Hemodialysis System due to reports of clinically significant fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm. This could result in a decrease or increase in the volume of the circulating blood, which may … [Read more...]