May 7, 2013
Cardinal Health discovered that 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 dissembling 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.
On March 26, 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. Customers are also asked to confirm receipt of the notification letter and completion of the labeling activity by returning an Acknowledgement Form. If customers are not comfortable with adding the WARNING LABEL to the kits or using these kits, they should contact Cardinal Health at 1.800.766.0706 for further instructions.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.
Click here for more information, including a list of the products, catalog numbers and lot numbers.