Safety Alerts for Surgical Gowns and Drugs

The North American Spine Society (NASS) sent two spine safety alerts to its members in January 2020 about drugs and surgical gowns.

The first alert on January 24, pertained to Cardinal Health notifying customers on January 16 regarding “potential quality issues affecting some the company’s Level 3 surgical gowns and accompanying PreSource procedural packs.”

The second, on January 27, pertained to Fusion IV Pharmaceuticals, Inc’s. (dba Axia Pharmaceutical), January 15 voluntary nationwide recall of all sterile drug products within the expiration dates due to a lack of assurance of sterility.

Cardinal Health Surgical Gowns

The NASS gown alert stated the FDA “…understands the issue with the Cardinal Health gowns may already be impacting patient care at health care facilities, such as the cancellation of non-elective surgeries.”

Jeff Shuren, M.D., head of the FDA’s Center for Devices and Radiological Health, said, “There are very real consequences that medical device supply chain disruptions can have on patients, and FDA is committed to taking what steps we can to mitigate any adverse patient impact. At this time, FDA is not aware of any patient harm because of this issue.”

According to NASS, “Customers should immediately discontinue use of all affected surgical gowns and PreSource procedural packs…. Customers with questions about whether their own inventory is affected should contact Cardinal Health…” at the Cardinal Health Support Center at 800-326-6457.

“Health care facilities may contact FDA at deviceshortages@fda.hhs.gov with information about potential or actual supply issues.”

“Gowns are classified into four levels of barrier protection based on their liquid barrier performance. Level 3 gowns provide moderate risk protection and are used in a wide-range of surgical procedures, such as open-heart surgery and knee replacements. They are intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids, and particulate material.”

Axia Pharma Sterile Drug Products Recall

The NASS drug alert informed members that Axia notified its customers by letter and direct outreach to arrange for the return of all recalled products. Customers that have any recalled products should stop using the drugs and return them to: FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical.

You can read the safety alert here.

Here is a link to a full listing of the products, including lot numbers and expiration dates, being recalled.

The alert noted that Axia had not received any reports of adverse events related to this recall and was recalling all sterile products out of an abundance of caution.

Consumers with questions regarding this recall can contact Erdwin Orellana at Axia by phone number: (877-685-8222) or e-mail address ecallassistance@axiapharma.net.