Pharmacy teams in England have been told to dispose of any unused out-of-date Cardinal Health Type IIR face masks sent to them by wholesalers in March and April, the Pharmacist has learned.

The Type IIR surgical face masks from supplier Cardinal Health are potentially harmful to staff wearing them if the foam strip on them flakes and enters the mouth or airways, the Department of Health and Social Care (DHSC) said after an MHRA assessment of the products.

The masks initially came from the government's pandemic stockpile and were distributed to community pharmacies across England at the beginning of the pandemic.

The face masks, sent to community pharmacists as well as other primary care clinicians, were well past their 2016 expiry dates. But this had been concealed with a sticker displaying a 2021 expiration date.

These masks were quickly deemed ‘safe to use’ by the DHSC. More recent tests found the masks to have ‘defects’.

A spokesperson from the DHSC told the Pharmacist that ‘although these masks meet the breathability, filtration and splash resistance requirements to protect against infection, in light of ongoing monitoring and testing from the manufacturer on the masks, the MHRA recommends that all lots of this product are disposed of locally.’

Phoenix, a medical wholesaler, told the Pharmacist that they supplied 3,473 customers, including pharmacy teams with the masks.

‘We were notified that NHS Supply Chain had received some complaints about Cardinal Type IIR face masks from health and care staff. Although these masks meet the breathability, filtration and splash resistance requirements of BS EN 14683, further testing resulted in the MHRA recommending that all lots of this product be disposed of.

‘They also asked that ‘customers who received the Cardinal Type IIR face masks, requesting they stop using, quarantine all affected shipments and dispose of them locally.’

Many pharmacy teams have not received the warning

Pharmacists who received out of date masks made by Cardinal Health back in March have said they have not received any warning from wholesalers regarding the faulty masks.

A spokesperson from McKesson UK – AAH’s parent company – told the Pharmacist that they arestill in the process of informing customers who may have received the masks to dispose of them.

‘Along with other wholesalers, we have been advised by DHSC that batches of Cardinal Type IIR face masks supplied to us in March and April by them should be destroyed.

‘We are informing our customers who purchased these masks from us so that they can take the necessary action if they have any unused stock and we are working through the process of replacing or refunding with the DHSC. Specific lot numbers have been specified and we do not know if we were the recipient of any of those, though we have received no complaints about the masks.’

Pharmacy wholesaler, Alliance Healthcare, told the Pharmacist that following the announcement regarding Cardinal Type IIR masks, the body is ‘seeking further guidance from the Department of Health and Social Care.’

Cardinal Health has been approached for comment.

More to follow…