Cardinal Health is recalling pre-assembled filter and anesthesia circuits that come in a variety of pre-made packs, including those for laparoscopic gynecology, general laparoscopy, knee arthroscopy, shoulder arthroscopy and total joints.

The pre-assembled filters and circuits "are intended to provide respiratory support to deliver oxygen, air, and nitrous oxide in a controlled manner to a patient," says the recall alert. However, if the outer plastic packaging on the components is removed without proper dissembling of the components, "remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction in airflow." Such impedance could result in low blood oxygen (hypoxia), suffocation and death.

Because of the severity of the potential consequences, the recall is Class I. The FDA and Cardinal Health are asking that customers "examine their inventories, identify and locate the products affected, notify clinicians, and affix a warning label on the front of each kit," to warn clinicians to remove and discard the preassembled circuits and filters from pre-made kits.

A Cardinal Health spokesperson says that all customers "affected by the recall have been notified of the recall, have confirmed receipt of notification and have taken action. Any customers who have not been notified are not affected by this recall."

Stephanie Wasek