Timesco Single Use Resuscitators (PVC) (ICN 1200)

Important Customer Notice Field Safety Notice

Ref: 2021/1200 ICN Number: 1200

MHRA: 2021/002/004/487/012

NHSSC: 74

Alert:        

  • Three Lions Limited has issued a Field Corrective Action Notice affecting  seven products and lot numbers of the Timesco single use resuscitator (PVC) following discovery of a faulty air inlet one-way valve. The flapper valve may be  severely warped.
  • Warping  of the flapper valve may reduce the volumetric flow of air from the bag into the patient during use.
  • To date, Three Lions Limited has received one report of injuries related to this issue.

Products Affected:  

  • There are seven products listed in the Field Safety Notice, with six of the affected products available through NHS Supply Chain.
  • Please see our Downloads ▼ section to refer to the Field Safety Notice and product listing for further information on the affected product codes.
  • Please note it is the model and lot numbers only in the Field Safety Notice that are affected and require the checks detailed. All other products should continue to be used as normal.
NPC MPC Description Lot Number
FDE768 TDM-BVM-1600 Timesco Adult Resuscitator 1600ml 2007013
FDE815 TDM-BVM-1600 Timesco Adult Resuscitator 1600ml 2007014
FDE770 TDM-BVM-1400 Timesco Adult Resuscitator 1400ml 2007012
FDE771 TDM-BVM-1000 Timesco Adult Resuscitator 1400ml 2007011
FDE772 TDM-BVM-0550 Timesco Child Resuscitator 550ml 2007009
FDE769 TDM-BVM-0300 Timesco Infant Resuscitator 350ml 2007008
Not available via NHS Supply Chain TDM-BVM-0551 Timesco Child Resuscitator 550ml 2007010
  • NHS Supply Chain has engaged with the manufacturer and MHRA and will not at this time recall lots in trusts which we have supplied in absence of MHRA advice to do so.
  • As a precaution, NHS Supply Chain has checked current stock holding and confirm all future issues will be of un-affected lot numbers.

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share this document with all users of the affected products.
  • Complete and return the acknowledgement form on page of the notice to info@timesco.com.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor

Downloads ▼

  • 1200 Timesco Customer Response Form

    A PDF of the Customer Response Form for ICN 1200.
  • 1200 Timesco Field Safety Notice

    A PDF document of the Field Safety Notice for ICN 1200.
  • 1200 Timesco Product Listing

    An Excel file detailing the affected product codes for ICN 1200.
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