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Important customer notice Field Safety Notice

ConvaTec High Concentration Oxygen Masks

Ref:2017/151

ICN number:151

  • Date:07/09/2017
  • Product area:

Issue:

Recall Ref 22

  • ConvaTec has updated the field safety notice issued in May 2017 adding further lot numbers for recall.
  • The High Concentration Oxygen Masks were recalled following an internal assessment of product reports which has confirmed that these devices are not meeting their expectations. In some cases, the tubing has been found to disconnect from the oxygen mask, prior or during use, causing a disruption in supply of oxygen.

Impact

  • High Concentration Oxygen Masks are intended to delivery high concentration oxygen to patient airways. For this reason and to address any potential risk of harm, all of the affected products should not be used.
  • The additional lot numbers on the revised field safety notice are mpc 106mm lot number 13-32 and mpc108mm lot numbers 13-32 and 105471
  • Our Distributor Unomedical advice NHS Supply Chain was supplied lot number 13.32 for 106mm only in 2014, this is NPC FDD763.

Next Steps:

  • Please log onto NHS Supply Chain website and click on the link below to view full details of the Field Safety Notice
  • Customers should follow the instructions contained in the Field Safety notice including checking all stock, cease use prior to arranging a return of affected lot numbers found.
  • Customers are to complete the ConvaTec Recall Response Form and return it to recalls.fsn@supplychain.nhs.uk
  • For products purchased via NHS Supply Chain please also contact your NHS Supply Chain Customer Service Advisor with full details to enable us to arrange return for full credit using reason code 7 “supplier recall”. All products returned no later than Friday 22 September 2017.


For further information please contact your NHS Supply Chain Customer Service Advisor.

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Should you require further information about this contract, including pricing and how to order the products, please contact your NHS Supply Chain account manager using the link below.

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