by wisepowder
Masks: type IIR
Reissued: No change to action. Clarification of distributor’s responsibilities. Removed table of lot numbers from device details section as all lot numbers remain affected.To get more news about type IIR mask factory, you can visit tnkme.com official website.
Action
Identify, stop using and immediately dispose of all lots relating to BWM028 of the Cardinal Type IIR masks. See below for lot numbers.
If you have a shortage of Type IIR masks, please notify National Supply Distribution Response (NSDR) on 0800 915 9964 who will arrange an emergency delivery if required.
The PPE dedicated supply channel sent their customers an Important Customer Alert on 26 June 2020 (ICA: 003). The MHRA is publishing this Medical Device Alert to help broadcast the actions in the ICA.
Although these masks meet the breathability, filtration and splash resistance requirements of BS EN 14683, in light of ongoing monitoring, further complaints reported and testing by Medline Industries on the masks, the MHRA recommends that all lots of this product are disposed of locally.
Safety details
You will see that boxes have been labelled with a new expiry date. This is because they were subject to shelf life extension testing by Medline Industries in 2013/2014. They passed a number of relevant tests to support a new expiry date for this stock to be held in the Pandemic Influenza Preparedness Plan (PIPP) stockpile.
When potential issues were identified in May 2020, a sample size of seven lots was put through additional testing by Medline Industries in June 2020. Six lots did not pass a material inspection of the foam strip.
However, these masks meet the breathability, filtration and splash resistance requirements of BS EN 14683.
Reissued: No change to action. Clarification of distributor’s responsibilities. Removed table of lot numbers from device details section as all lot numbers remain affected.To get more news about type IIR mask factory, you can visit tnkme.com official website.
Action
Identify, stop using and immediately dispose of all lots relating to BWM028 of the Cardinal Type IIR masks. See below for lot numbers.
If you have a shortage of Type IIR masks, please notify National Supply Distribution Response (NSDR) on 0800 915 9964 who will arrange an emergency delivery if required.
The PPE dedicated supply channel sent their customers an Important Customer Alert on 26 June 2020 (ICA: 003). The MHRA is publishing this Medical Device Alert to help broadcast the actions in the ICA.
Although these masks meet the breathability, filtration and splash resistance requirements of BS EN 14683, in light of ongoing monitoring, further complaints reported and testing by Medline Industries on the masks, the MHRA recommends that all lots of this product are disposed of locally.
Safety details
You will see that boxes have been labelled with a new expiry date. This is because they were subject to shelf life extension testing by Medline Industries in 2013/2014. They passed a number of relevant tests to support a new expiry date for this stock to be held in the Pandemic Influenza Preparedness Plan (PIPP) stockpile.
When potential issues were identified in May 2020, a sample size of seven lots was put through additional testing by Medline Industries in June 2020. Six lots did not pass a material inspection of the foam strip.
However, these masks meet the breathability, filtration and splash resistance requirements of BS EN 14683.
