ScopeFlow Water Bottle Tubing Product Withdrawal from Market (ICN 1211)

Important Customer Notice Recall

Ref: 2021/1211 ICN Number: 1211

MHRA: 2021/002/008/601/004

NHSSC: 81

Alert:        

  • Partners for Endoscopy (PFE Medical) has issued an urgent Field Safety Notice to recall all Non-Pure Scope Flow semi disposable water bottle adaptors that do not have a built-in filter.
  • The Field Safety Notice states that if you are using a semi disposable water bottle that does not have a built-in filter, the air in the  water bottle is from the room air, and if a previous patient has had Covid-19, the water may be carrying the virus.

Products Affected:

  • There are four NHS Supply Chain product affected, available via our eDirect route:
NPC MPC Description Unit of issue
FAL13747 PFE145 ScopeFlow bottle top for Olympus Case 10
FAL13749 PFE145C02 ScopeFlow bottle top for Olympus CO2 Case 10
FAL13750 PFE165C02 ScopeFlow bottle top for Fuji CO2 Case 10
FAL17986 PFE165 ScopeFlow bottle top for Fujinon Case 10
  • Please note this does not affect the ScopeFlow Pure range.

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share this document with all users of the affected products.See our Downloads ▼ section
  • Complete and return the acknowledgement form on page 3 of the notice to Andrea Goodier by fax: 01782 323148 or email: andrea@pfemedical.co.uk.
  • PFE Medical confirm all customers have been contacted and they are exchanging immediately, free of charge, and arranging collection of the affected products.
  • If you have not been contacted, or require further information, please contact Andrea Goodier at PFE Medical; or contact your NS Supply Chain Customer Service Advisor for assistance.

 

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

Downloads ▼

  • 1211 PPE Medical Field Safety Notice

    A PDF document of the Field Safety Notice for ICN 1211.