Maine purchased more than 2 million potentially counterfeit N95 respirators that are now part of a nationwide recall and replacement effort, and 161,000 of the masks have been distributed to school nurses, health care facilities and state workers in Maine since November.

The 1860 mask Photo courtesy of Maine Division of Procurement Services

Maine’s Division of Procurement Services has notified respirator recipients and initiated a process to replace the masks as supply allows. About 2 million of the respirators with lot numbers subject to the recall remain at state warehouses.

The recall notice from the National Recall Alert Center is specific to blue, medical-grade 3M respirator models 1860 and 1860S. The masks must be individually fitted and are intended for personnel such as nurses or doctors and are not generally made available to the public.

The recall alert indicates the masks carry a significant risk of being counterfeit, so it is unknown whether they meet standards for N95 respirators set by the National Institute for Occupational Safety and Health (NIOSH) at the U.S. Centers for Disease Control and Prevention.

“We have alerted those affected by this recall and are coordinating to provide alternative respirators as available,” Jaime Schorr, Maine’s chief procurement officer, said in a written statement Friday.

Federal authorities are investigating a massive counterfeit N95 mask operation that sold fake 3M masks to hospitals, medical facilities and government agencies in several states, including New Jersey, Washington, Ohio and Minnesota. The foreign-made knockoffs are becoming increasingly difficult to spot and could put health care workers at grave risk of contracting the coronavirus.

“The state of Maine has contacted federal authorities to determine whether these recalled respirators should be incorporated into its investigation alongside other states,” Schorr said in the statement.

The vendors who sold the masks to Maine “represented to the state that the items were NIOSH-approved, authentic 3M brand N95 respirators,” the statement said. “Prior to ordering, the state was provided samples from the vendors, which were inspected for quality through fit testing. These samples passed the quality review.”

Some signs that a respirator may be counterfeit include a lack of markings or approval numbers on the filtering face piece or headbands; missing or misspelled NIOSH markings; claims of approval for use by children; and ear loops instead of headbands, according to the U.S. CDC website.

Maine’s procurement division is investigating the matter and is in direct communication with officials at 3M, including the 3M COVID-19 Fraud, Price Gouging and Counterfeit Product Response Team. The division also contacted the Office of the Maine Attorney General and, if investigations show the masks are fake, will seek full reimbursement.

The division’s statement didn’t say how much the state paid for the counterfeit masks. It also didn’t address whether the state has enough respirators in stock to replace the recalled masks in short order or must buy additional masks amid continuing shortages of personal protective equipment.

The 1860S mask Photo courtesy of Maine Division of Procurement Services

The division didn’t respond to a request for additional information Friday night. The names of the vendors are being withheld until 3M confirms the masks are fake.

State officials have asked recipients of the recalled respirators to put them aside, unused and unopened, until the investigations are completed. Recipients include school nurses, health care facilities and workers within the Department of Health and Human Services.

About 140,000 recalled respirators went to 55 schools and districts for nurses and other clinical staff. The Maine Department of Education has contacted affected districts and is working with the Division of Procurement Services to replace the stock, which was intended to support them for the next several months.

About 3,000 recalled respirators were sent to 64 health care facilities. The Maine CDC has alerted the facilities and will work with them to replace the masks, the statement said.

The remaining 18,000 recalled respirators were distributed to DHHS employees with patient-facing roles. They have been removed from circulation and alternative N95 respirators will be made available.

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