A Chinese manufacturing company has been charged with shipping more than 140,000 defective face masks, marketed as “KN95,” to the U.S. in the middle of the Wuhan coronavirus (COVID-19) pandemic.
According to federal prosecutors, the Hong Kong-based Crawford Technology Group sold masks to a U.S. distributor claiming that they met the KN95 standard — China’s equivalent of the N95 standard. However, subsequent testing showed that the face masks only filtered less than 50 percent of small particles during testing — well below the 95 percent filtration requirement for both N95 and KN95 masks.
“It is not enough that this pandemic has upended lives around the world and caused countless suffering and hundreds of thousands of deaths,” said Jason Molina, a special agent with Homeland Security Investigations. “In the midst of that, we have companies like this that exploited this tragedy for financial gain and in the process put millions of lives at risk.”
Chinese face masks supposedly complied with standards — they didn’t
Crawford had sold about $150,000 worth of the defective masks to a New Jersey electronics distributor around April. According to prosecutors, the packaging of the masks claimed that they complied with established standards in China and the European Union. In addition, Crawford’s website stated that the masks have “four layers of protection” and that they passed recent Chinese standards for respirators.
The substandard nature of the imported masks was discovered when Customs and Border Protection held them for inspection when they arrived at John F. Kennedy International Airport on May 6. Testing conducted on 19 of the masks by the National Institute for Occupational Safety (NIOSH) found that they only filtered out 14.6 to 44.2 percent of small particles.
Crawford now faces charges of making false claims about their face masks’ filtration standards in violation of the Food, Drug, and Cosmetic Act, which carries a maximum fine of $200,000.
Substandard masks have been caught before
The Crawford case is just the latest example of Chinese companies taking advantage of the shortage of medical equipment due to the ongoing pandemic.
In May, the Food and Drug Administration (FDA) revoked the approval for more than 60 Chinese companies to import KN95 face masks to the United States. Testing conducted by NIOSH found that, much like those produced by Crawford, the masks produced by these companies failed to pass filtration standards.
Part of the reason these masks made it into the U.S. was that the FDA authorized the import of Chinese-made masks that hadn’t been tested to overcome shortages in early April. This decision was made on the condition that the face masks would be tested by independent labs.
Since then, millions of masks have made it into the country.
How much damage did these substandard masks do?
Crawford’s substandard face masks, alongside previous cases of substandard masks from other Chinese companies, raises questions of just how many of these substandard masks have made it into the U.S. and been used by healthcare workers, exposing them to harm.
According to data from the Centers for Disease Control and Prevention, more than 80,000 healthcare workers have been infected by the coronavirus and over 400 have died. The CDC also acknowledges that their tally is an undercount and some reports have put the number of deaths at around 600. (Related: CDC claims coronavirus killed nearly 400 American healthcare workers.)
An incident in Missouri where thousands of Chinese masks distributed to healthcare workers were recalled for not meeting standards shows that defective masks did make it into general use. With this in mind, it stands to reason that some of the blame for why some healthcare workers caught the coronavirus falls on these defective Chinese masks. It also implies that the FDA’s decision to allow untested Chinese masks to enter the country may have put American healthcare workers at higher risk of infection.
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