California Recalls N95 Masks from Santa Clara Company | Virus World | Scoop.it

California officials had distributed 7.2 million N95 masks from Advoque, a Santa Clara-based company that normally makes retail displays. A $90 million state contract with a South Bay company that started manufacturing N95 masks during the coronavirus pandemic is in jeopardy after the company’s respirators failed to pass muster with federal inspectors.  California officials had distributed 7.2 million N95 masks from Advoque, a Santa Clara company that normally makes in-store product displays, before the National Institute for Occupational Safety and Health last week revoked the temporary certification it had previously granted the business. Brian Ferguson, a spokesman for Gov. Gavin Newsom’s Office of Emergency Services, said the state had another 3 million masks from the company on hand as of Sept. 8.  A copy of the state recall notice, posted online by the group California Advocates for Nursing Home Reform, told recipients, “If you have current inventory of Advoque N95 masks … immediately cease use and distribution of this product.” Neither the state nor Advoque disclosed why the masks’ certification was revoked.

 

A crush of demand for N95 masks, which experts say offer the most protection from the spread of COVID-19, has created a global shortage since the early days of the pandemic, putting California and other states in a desperate scramble to obtain millions of the masks for health care workers and other critical employees. The shortage was so great that many health care facilities and elder care homes asked their workers to conserve and reuse masks and other protective equipment. That frantic market has led to large and expensive contracts with less-experienced manufacturers such as Advoque that only weeks earlier were making entirely different products. The Advoque contract was inked in June, according to Politico, around the time a far bigger — nearly $1 billion — N95 mask deal with the Chinese car manufacturer BYD appeared at risk of falling apart as the company similarly struggled to get federal certification. Those problems were eventually resolved, and California later extended its contract with BYD. State authorities began recalling Advoque’s masks once they found out about the revoked certification, Ferguson said, replacing them with other certified respirators. Advoque Chief Business Officer Paul Shrater wrote in a letter to customers Thursday that the company is working with federal regulators to recertify its masks, a process he said is expected to take two more weeks. In the meantime, Shrater said Advoque is not recalling its masks but instead providing a “product replacement program as a courtesy to our customers,” who can exchange their inventory for certified products once they receive NIOSH approval.

 

As for that $90 million contract, Ferguson did not say how much the state has paid Advoque so far. But he said the contract requires the vendor to maintain its certification. “The contract with this vendor has strong provisions to safeguard the state and the administration is exploring appropriate legal and contractual actions to protect the interests of Californians,” Ferguson wrote in a statement.