The August 2012 MedSun

Recalls and Safety Alerts:

Arrow International, Inc. Multi-Lumen Venous Catheterization Set with Blue FlexTip ARROWg+ard Catheter: Class I Recall
The device's labeling erroneously states that the product "contains no medication," however; the device contains chlorhexidine and silver sulfadiazine...

CareFusion EnVe Ventilators: Class I Recall
A leak may occur in the patient breathing circuit or the system, resulting in the ventilator not holding the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously...
Hospira Injectable Drug Products: RecallThere may be potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution...
Maquet Medical Systems USA FLOW-i Anesthesia System: Class I Recall
A technical alarm may be generated on the FLOW-i system when using the Manual/Automatic (MAN/AUTO) switch to change ventilation modes from manual to automatic or from automatic to manual...
Alere Triage Diagnostic Tests (Multiple Tests): Class I Recall
Identified lots may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results...
GE Healthcare Aestiva/5 7900 Ventilator - Class I Recall
There is a potential for two vaporizers to deliver each agent at the same time which may result in over-delivery of a single agent if both vaporizers contain the same agent, or in delivery of more than one agent...
FDA Safety Communication: UPDATE on Advanced Sterilization Products (ASP) Sterrad Cyclesure 24 Biological Indicators Revised Expiration Dates
The FDA is issuing this communication to inform personnel at facilities that utilize Sterrad sterilizers of the following updates...
Stryker Initiates Voluntary Product Recall of Modular-Neck Stems
Patients who received a Rejuvenate Modular or ABG II modular-neck stem are encouraged to contact their surgeon...
CareFusion Airlife Infant Breathing Circuit: Class I Recall
Recall due to the risk that the Y-adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system...

Educational Materials:

FDA Website - Tubing and Luer Misconnections: Preventing Dangerous Medical ErrorsThis recently updated website explains how misconnections occur, provides real-life examples of misconnections, and offers tips and additional resources for healthcare professionals on how to prevent them...

New Product Approvals:
 

  
First Rapid Home-Use HIV Kit Approved for Self-Testing
The FDA has approved the OraQuick In-Home HIV Test, a rapid home-use HIV test kit that does not require sending a sample to a laboratory for analysis...



FDA Proposed Rule:
Unique Device Identification Proposed Rule