Cardinal Health voluntarily recalled more than 2.5 million packs that contained potentially contaminated surgical gowns, the wholesale distribution giant announced Thursday.
The recall comes about a week after Cardinal recalled 9.1 million surgical gowns that may have been exposed to bacteria and other contaminants at unauthorized manufacturing sites in China, which may have infected patients. While Cardinal sterilizes the products after they are manufactured, it could not verify that they were sterile because it could not quantify their exposure to bacteria.
The supplies in the 2.5 million packs were not individually separated by sealed packages, while 374,794 packs had individually sealed components in the "sterilization pouch." Cardinal instructed customers to discard all other components in those packs.
"I apologize to patients and our customers. We understand the gravity of this situation and the disruptions to the healthcare system that will impact patient care," Cardinal CEO Mike Kaufmann said in prepared remarks. "We are fully committed to making this right, and we are doing everything we can to ensure it never happens again."
Cardinal conveyed new information in their most recent press release, indicating that issues with Siyang HolyMed started in 2018. In spring 2018, Cardinal learned that Siyang outsourced some of its production to an unauthorized facility, according to the press release. The company conducted a quality review, concluded there was no impact to its products and did not inform the Food and Drug Administration, Cardinal said.
Cardinal executives previously told Modern Healthcare that the company received a tip on Dec. 10, 2019 that Siyang was using two unauthorized sites. It halted imports on Dec. 20 and cut ties with Siyang. Cardinal issued a hold of all surgical gowns manufactured at Siyang on Jan. 10 and notified the FDA. It recalled the Level 3 surgical gowns on Jan. 22, which cost about $96 million, Cardinal estimated in its second-quarter earnings report.
Potential government investigations related to the gown recall, civil or criminal sanctions and licensure suspensions may obscure financial outlooks, the company noted in the report. Cardinal told Modern Healthcare that it was considering monetary compensation for impacted providers.
Second-quarter operating earnings decreased 34% to $334 million on revenue of $39.7 billion, according to generally accepted accounting principles. Cardinal, which is also facing a $5.6 settlement related to its role in the opioid crisis, reported $145.5 billion in revenue in 2019.
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. The windows at the inspected site were open, it lacked appropriate hand-washing stations, food was in the manufacturing area and the door wasn't secure, the company said.
Hospitals have been scrambling to source alternatives; some had to delay surgeries. They are bracing for potential long-term impacts to the supply chain as other manufacturers try to increase capacity.
About 2,807 total facilities received potentially contaminated gowns from Sept. 2018 to Jan. 10, 2020, Cardinal estimates. As of now, hospitals, Cardinal and other stakeholders are still assessing the potential quality impacts.
"We don't know if it really started in September or before," Dr. Marcus Schabacker, CEO of the ECRI Institute, told Modern Healthcare last week. "There is clearly a potential for it to be widespread."
Cardinal tasked third-party experts to review its quality-assurance processes and business practices. Cardinal's board formed a special committee to oversee the recall, the company said.