Urgent Field Safety Notice: Surgical Masks

The Bluetree Group has issued an urgent field safety notice relating to Obisk Type IIR Masks.

A problem has been identified with masks manufactured using a particular batch of material. The product meets the requirements for bacterial filtration efficiency, microbial cleanliness and breathability however it does not achieve the required splash resistance to be categorised as a Type IIR. As such it offers infection control equivalent to a Type II surgical mask with the breathability performance of a Type IIR.

Products affected 
Batches of the following products are affected by this Field Safety Notice: 

Code	Product Description	Packaging	UDI-DI	Manufacture Date
OB11R	Obisk Disposable Type IIR Surgical Masks with Ear Loops	Supplied in boxes of 50 masks	05056423700060	July 2021
OB11RT	Obisk Disposable Type IIR Surgical Masks with Tie Backs	Supplied in boxes of 25 masks	05056423700220	July 2021

 

The following batches of the above products are affected: 

Batch / Lot Number	Product Code
101000345	OB11R
101000346	OB11R
101000348	OB11R
101000349	OB11R
101000350	OB11RT
101000354	OB11R

 

More information can be found on the Urgent Field Safety notice relating to Obisk Type IIR Masks provided by The Bluetree Group. 

Please review the content of this field safety notice and check your stock for the affected product code and lot number.

If you have any stock from the affected batch, please isolate them immediately to prevent them from being used or distributed. Any affected batches found can be disposed into standard waste stream.

Published 3rd November 2021