Regulatory Focus™ > News Articles > Plastic Packaging Leads to more than a Dozen Major Device Recalls for Cardinal Health

Plastic Packaging Leads to more than a Dozen Major Device Recalls for Cardinal Health

Posted 06 May 2013 | By Alexander Gaffney, RAC 

A little piece of plastic is causing big headaches for Cardinal Health after its Medical Products and Services Division announced more than a dozen Class 1 recalls because of the potential for a device's plastic packaging to get stuck in its filter, obstructing airflow to a patient being operated on.

The recalls affect at least 13 device kits manufactured by the company, the majority of which seem to be contained within or otherwise related to Cardinal's Presource PBDS kit  product line, of which 4,571 are now being recalled.

On the US Food and Drug Administration's (FDA) MedWatch website, the agency explains that "various pre-source kits contain a pre-assembled Filter and Anesthesia Circuit that 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 of airflow," the notice explains.

Customers with the devices are being advised to quarantine the devices, and label them with a warning indicating that the anesthesia circuit and filter should be discarded.

The kits were only distributed in Arkansas, Mississippi, South Carolina and Tennessee, according to MedWatch.


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