Various Presource Kits containing a pre-assembled anesthesia circuit and filter may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction in airflow. This may result in serious adverse health consequences including low blood oxygen (hypoxia), suffocation, and death.
Cardinal Health’s pre-assembled Filter and Anesthesia Circuit are intended to provide respiratory support to deliver oxygen, air, and nitrous oxide in a controlled manner to a patient. These assemblies are included in various Presource convenience kits including, but not limited to, gynecology laparoscopy kits, general laparoscopy kits, knee arthroscopy kits, and total hip kits.
The affected Presource Kits were manufactured from March 2012 to March 2013 and were distributed from March 2012 to February 2013. Cardinal Health notified customers of the problem and products affected. Customers should examine their inventories, identify and locate the products affected, notify clinicians, and affix a warning label on the front of each kit. The warning label instructs clinicians to remove and discard the anesthesia circuit and filter assembly.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe.