Urgent Recall on Timesco Single Use Resus Bag Valve Mask – RISK TO HEALTH

Medical Device Field Safety Notice (No: 20210112)

This patient safety alert advises you that Three Lions Limited has initiated a voluntary Field Safety Corrective Action for the above resuscitation product. This is due to warping of the Flapper Valve on seven specific lots of seven models of the Timesco Single Use Resuscitator (PVC) as listed below.

IMMEDIATE ACTION REQUIRED

  • You should assess your resuscitation stocks using the instructions below
  • If any of these affected products are identified, replacements should be ordered immediately using the details below
  • If your stocks are not within the scope of the affected devices below, please continue to use it.
  • In affected batches the flapper valve is severely warped. This may reduce the volumetric flow of air from the bag into the patient during use.
  • If you would like further guidance, please contact one of our team on 0843 506 55 60 or email the manufacturer at service_3l@163.com.

 

Product Description

Product Batch Number Product Name
TDM-BVM-1600 2007013 Timesco Single Use Resuscitator (PVC)

– Adult 1600ml with No.5 Mask
TDM-BVM-1600W 2007014 Timesco Single Use Resuscitator (PVC)

– Adult 1600ml with No.5 Mask with 60 cm H2O Pressure Relief Valve
TDM-BVM-1400 2007012 Timesco Single Use Resuscitator (PVC)

– Adult 1400ml with No.5 Mask
TDM-BVM-1000 2007011 Timesco Single Use Resuscitator (PVC)

– Adult 1000ml with No.5 Mask
TDM-BVM-0550 2007009 Timesco Single Use Resuscitator (PVC)

– Child 550ml with No.1 & 2 Mask
TDM-BVM-0551 2007010 Timesco Single Use Resuscitator (PVC)

– Child 550ml with No. 0 & 1 & 2 Detached Mask
TDM-BVM-0300 2007008 Timesco Single Use Resuscitator (PVC)

– Infant 350ml with No. 0 PVC Mask

 

RISK TO HEALTH:

The Flapper Valve is severely warped. This may reduce the volumetric flow of air from the bag into the patient during use. To date, Three Lions Limited has received 1 report of injuries related to this issue.

Further information on this alert can be found HERE

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