AUDIENCE: Anesthesiology, Biomedical Engineering, Risk Manager, Surgery
ISSUE: 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.
BACKGROUND: 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.
RECOMMENDATION: Cardinal Health notified customers of the problem and products affected (refer to the Recall Notice for a full list of affected products). 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[05/07/2013 - Recall Notice - FDA]