A Chinese mask-maker was charged on June 17 for exporting to the United States more than 140,000 defective masks that were marketed as KN95 respirators, the latest case targeting companies allegedly selling faulty medical gear amid the pandemic.
Federal prosecutors alleged China-based Crawford Technology Group (Hong Kong) Co. sold masks to a U.S. distributor claiming to meet standards filtering 95 percent of small particles. The masks were purported to be KN95 respirators. Such masks, which have a similar filtration standard to N95 respirators, are used by health care workers.
However, tests found that the masks only filtered 22 percent of small particles—well below the 95 percent filtration standard, the U.S. Department of Justice said.
The prosecution was part of efforts to stem the flow of counterfeit and substandard personal protective equipment into the United States. U.S. hospitals and authorities have turned to foreign firms, particularly from China, to supply medical products amid a severe shortage caused by the pandemic. However, much of the imported gear hasn’t met quality standards after testing.
Around the world, many countries have recalled or sent back faulty masks, test kits, and protective suits manufactured in China.
U.S. Customs and Border Protection agents inspected the shipment of masks from Crawford, which arrived at John F. Kennedy International Airport in New York in early May, according to the complaint filed by the U.S. Attorney’s Office for the District of New Jersey. The unidentified distributor paid Crawford about $150,000 for the masks, it said.
The packaging claimed the masks complied with established standards in the European Union and China, and the company’s website said the respirators have “4 layers of protection” and “passed the national standard 2626-2000 test,” according to the Justice Department.
Prosecutors charged Crawford with making false claims about the mask’s filtration standards in violation of the Federal Food, Drug, and Cosmetic Act. The charge carries a maximum fine of $200,000.
“Defective and misbranded personal protection equipment is a danger to all who unwittingly purchase and use it,” U.S. Attorney Craig Carpenito said in a press release.
In May, the Food and Drug Administration revoked approval for more than 60 N95-type mask manufacturers in China to export to the United States, after testing found that many of their products didn’t meet quality standards.