Cardinal Health is voluntarily recalling 9.1 million potentially contaminated surgical gowns, 7.7 million of which were distributed to 2,807 facilities worldwide over the course of more than a year, the company shared exclusively with Modern Healthcare.
The recall applies to certain lots of AAMI Level 3 single-sterile and non-sterile gowns that were distributed from Sept. 1, 2018, to Jan. 10, 2020. The potentially compromised gowns may have increased surgical-site infections given that the wholesale distribution giant could not ensure they were sterile, the company said.
Dublin, Ohio-based Cardinal estimates that 9.1 million gowns accounts for less than 3% of the industrywide supply, said Robert Rajalingam, the president of U.S. medical sales at Cardinal. At this time, the company has no confirmed reports of adverse events associated with the gowns, he said. The Food and Drug Administration confirmed that on Jan. 16, but did not verify there were no confirmed reports prior to deadline.
"We sincerely apologize for the disruption to the health system and patient care that this is causing," Rajalingam told Modern Healthcare. "Our primary priority is the safety of the healthcare workers and the patients they serve."
The company received a tip on Dec. 10, 2019, that one of its manufacturers, Siyang HolyMed in China, was using two unauthorized and unregistered sites to produce the Level 3 surgical gowns, which are used for open-heart surgery, knee replacements and other procedures. Cardinal confirmed the tip during an on-site investigation on Dec. 20, when the company immediately stopped doing business with Siyang and halted imports of the products into the U.S.
The gowns had increased bioburden levels, which identifies and quantifies bacteria, microbiological flora and other particulate matter before sterilization, but the exact amounts are unknown, according to Cardinal. The windows at the inspected site were open, it did not have appropriate hand-washing stations, food was in the manufacturing area and the door to that space was not up to code, the company said.
The gowns are shipped to sterilization sites after they are made. But Cardinal cannot ensure the products are sterile because of their unquantified exposure to bacteria during the manufacturing process.
The distributor placed a hold on several SKUs on Jan. 7. It then determined that it could not differentiate the product that came from the two unauthorized sites and other Siyang facilities, so it put all Siyang AAMI Level 3 lots on hold on Jan. 10, notified the FDA about the extent of the hold and sent notices to customers, the company said.
Cardinal maintained that it acted as it gathered information and tried to determine the scope of the quality issue.
Cardinal said that it is working closely with the other two largest distributors of surgical gowns, Owens & Minor and Medline, as well as group purchasing organizations to source alternative products. It is replacing them at no cost and has sent hundreds of employees to assist its customers. Most of the 9.1 million gowns were distributed to acute-care hospitals, ambulatory surgery centers and labs in the U.S. and Canada.
The Cleveland Clinic said last week it has pulled the products and is using alternatives. It will not cancel any surgeries, the health system noted.
Hospitals are going through their infection-control protocol while Cardinal is reviewing complaints and continues to test bioburden levels. The company is considering monetary compensation for the burden this placed on providers, Cardinal said.
"Patient safety is our No. 1 concern," Rajalingam said.
Cardinal instructed its customers to check all storage and usage locations, quarantine any from the impacted lot numbers and notify customers. Providers with Cardinal gowns should send the attached form to Cardinal, even if they were not impacted by the recall, and contact the company to arrange returns and replacements, Cardinal wrote in a notice sent out Jan. 21.
Customers can report any adverse events to the FDA.
Cardinal is not recalling some of the impacted packs that contained the products, but issued a hold on those items.
Cardinal, which is one of the largest distributors in the country, reported an operating income of $2.1 billion on revenue of $145.5 billion in 2019, up from $126 million of operating income on $136.8 billion of revenue in 2018, according to generally accepted accounting principles.