Airgas South, Inc., a distributor of industrial, medical, and specialty gases, just announced an expanded, voluntary recall of <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">medical gas products filled at its Chattanooga, Tennessee facility, the U.S. Food and Drug Administration (FDA) just announced.
The recall is being initiated as a precautionary measure because these products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices (cGMPs), which help assure that drug products meet required quality standards for quality, purity, and potency. The potential for serious medical events is remote and other than one initial complaint concerning a contaminated cylinder, which triggered the initial recall.
cGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
Airgas South is not aware of any other confirmed events involving cylinder contamination. The Company has no reason to believe that other contaminated cylinders will be found.
The recall involves high-pressure medical cylinders containing oxygen, nitrogen, air, nitrous oxide, carbon dioxide, and drug mixtures with expiration dates of July 13, 2010 through July 13, 2015; portable Walk-O2-BoutÂ®; oxygen cylinders with expiration dates of July 13, 2010 through July 13, 2012; and liquid cylinders (VGL) containing oxygen, nitrogen, carbon dioxide, and nitrous oxide with expiration dates of July 13, 2010 through July 13, 2011. The recall affects customers located in Tennessee, Alabama, and Georgia.
After an initial completed recall, further investigation at the Chattanooga facility identified cGMP issues and led to the decision to voluntarily recall additional products as a precaution. As an additional precaution, the Chattanooga facility has ceased medical filling operations until the investigation is complete and the root causes of the issues identified have been resolved.
Airgas Southâ€™s expanded recall notice asks customers who locate any cylinder(s) within the groups and with the expiration dates affected by the recall to clearly tag and quarantine those cylinders, and contact their local Airgas South representative. For medical inquiries, adverse event reporting or quality issues related to this recall, please contact Gregory P. Barnett, Safety Director, Airgas South at 770-590-6036, Monday to Friday 8:00am-5:30pm EST, or at firstname.lastname@example.org.
Airgas South has notified the U.S. Food and Drug Administration (FDA), and has issued recall communications to all customers involved.
Any adverse reactions associated with the use of these products may also be reported to the FDAâ€™s MedWatch Program by fax at 1-800-FDA-0178; by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or on the MedWatch website at www.fda.gov/medwatch.