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.
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 HERE.
- 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
the complete MedWatch Safety Alert, including a link to the Recall Notice, HERE.
Source: U.S. Food and Drug Administration (FDA) (Accessed: 5/7/2013)