Updated May 9, 2013, at 2:30 p.m. with a comment from Cardinal Health.
Cardinal Health (NYSE:CAH) announced a Class I recall of some of its pre-assembled filter and anesthesia circuit kits. The company discovered that plastic coverings on the kits could get stuck in the filter if the device is not dissembled in a certain way. Plastic in the filter could lead to airflow obstruction and presents a serious risk of patient harm.
The company requested that all hospitals and healthcare providers check for the products and put a warning label on each kit instructing doctors to throw away the anesthesia circuit and filter components. These laparoscopy convenience kits are used for gynecological, knee, total hip and some other laparoscopy procedures.
Cardinal Health spokeswoman Corey Kerr told MassDevice.com in an email that the company notified all affected customers and has received confirmantion that all have "taken action."
According to the FDA recall notice, this warning extends to 15 products that were manufactured from March 2012 to March 2013. Class I recalls are the most serious, and consumers should report adverse events to the FDA’s MedWatch, the agency reminded.
In February, the Dublin, Ohio-based medical device and pharmaceutical company said it planned to spend $2.07 billion acquiring medical supplies company AssuraMed, which itself just bought Invacare’s supplies business last month.