FDA Announces Surgical Gown Recall for more than 9 Million Units

surgical gown recall, medical device

The U.S. Food and Drug Administration (FDA) is warning healthcare facilities to stop using certain surgical gowns made in China due to the possibility that they are not sterile.  The recall issuer is medical device manufacturer Cardinal Health, but the gowns were made in China at a contractor facility.  The recall is causing alarm among many healthcare facilities in the U.S. as the FDA continues to investigate the risk.

Surgical Gown Recall Causing Alarm in U.S. Hospitals

In January, 2020, the FDA and Cardinal Health issued a statement warning healthcare facilities about possible quality issues with surgical gowns made in China.  The gowns subject to the recall include:

  • Level 3 Surgical Gowns
  • PreSource Procedural Packs

The PreSource packs contain the gowns and other surgical items.  Gowns that are not sterile could contaminate the other items in the package as well.

Surgical gowns are classified in three levels, which refers to the level of protection and liquid barrier performance they provide.  Level 3 gowns offer “moderate risk protection.” Surgeons use these gowns for surgical procedures like knee replacements and open heart surgery.  A level 3 gown protects both the patient and operating room staff from transfer of bodily fluids, microorganisms and particulate matter.

The surgical gown recall is causing alarm in hospitals across the U.S. as there is a shortage of surgical gowns appropriate for certain procedures.  One hospital in Tennessee reports they are rescheduling 200 surgeries because they do not have enough surgical gowns that are sure to be sterile.  Many healthcare facilities are expressing concern about how the recall will affect their patients.

The FDA statement says that,

“customers should immediately discontinue use of all affected surgical gowns and PreSource procedural packs that include these surgical gowns because the manufacturer cannot provide assurance the products are sterile.”

Reason for Surgical Gown Recall

Cardinal Health works with a supplier in China who manufactures the gowns and distributes them to healthcare facilities.  In January, 2020, Cardinal Health admitted that the Chinese supplier was using factories that are not registered with the FDA.  The facilities reportedly do not “maintain proper environmental conditions.”

The surgical gowns subject to the recall were manufactured in an environment where they were exposed to contaminants because:

  • The facility failed to provide hand sanitation
  • Windows in the production area were left open
  • Workers were allowed to eat in the production area

This is not the first time that Cardinal Health has had an issue with a Chinese supplier.  In 2018, the same supplier was caught using a facility that was not registered with the FDA.  Cardinal Health performed tests and determined that there was not an impact to the products.  They did not report the matter to the FDA.

The history of unregistered facilities and possible contamination is more than alarming given the nature of what surgical gowns are designed to do.  It appears that Cardinal Health has negligently allowed a supplier to produce possibly dangerous medical devices for two years.  Their failure to notify the FDA is also a great concern.

FDA Works to Mitigate Shortages Amid Recall

The FDA is actively working to mitigate surgical gown shortages, such as the one in Tennessee.  The agency is working to identify alternative gowns that have FDA approval and Level 3 protection.  Due to the concern about gown shortages, the FDA has a device shortages mailbox, where patients or healthcare providers can report a delay or shortage.  That mailbox is deviceshortages@fda.hhs.gov.

The FDA is working closely with Cardinal Health to identify the risk.  Furthermore, they will continue to communicate how the surgical gown recall may impact the public.  Customers who have questions about their inventory of surgical gowns can contact Cardinal Health directly to find out if their inventory is subject to the recall.  The FDA also urges consumers to report any adverse events they experience after using the gowns.

So far, the FDA and Cardinal Health are not detailing what the contamination risks are.  Anyone who plans to have surgery in the coming weeks should certainly talk to their healthcare team about the surgical gown recall.  It is important that patients avoid exposure to potential contamination during surgery.