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3M™ Ranger™ Blood and Fluid Warming High Flow Sets FSB658 and FFF430 (ICN 1875)

Important Customer Notice Field Safety Notice

Ref: 2022/1875 ICN Number: 1875

Alert:

  • The supplier 3M™ Ranger™ has issued a Field Safety Notice for specific Lots of Blood and Fluid Warming High Flow Sets.
  • There are two affected codes which are shown in the table below.
    • FSB658 is currently suspended and is unavailable to order
    • FFF430 was delisted from our catalogue earlier this year and is no longer available to order.
  • The Field Safety Notice is due to the identification of a manufacturing issue with the auto-venting bubble trap.
  • There is the risk of a blood or fluid leak while priming the sets and/or during fluid administration.
  • The products could be unable to deliver the therapy as per intended use and could expose the user to blood, blood products, and IV fluids during a leak.

Products Affected:

  • There are two NHS Supply Chain products affected:
NPC Product Description Supplier Code / MPC Route
FSB658 Blood and fluid warming High flow disposable set for Ranger blood and fluid warmer 24355 Stock
FFF430 Blood and fluid warming Hybrid High Flow Disposable Sets with Patient Line 24370 Blue Diamond
  • The affected Lots were supplied after 22 March 2022 and can be found in the Field Safety Notice letter below.

Next Steps:

  • Please read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
  • Please identify the affected products listed above and immediately cease use of affected models and lots of 3M™ Ranger™ Blood/Fluid Warming High Flow Sets.
  • Contact your NHS Supply Chain Customer Service Advisor with full details of the quantities of affected products in your possession including the Lot numbers.
  • Your Customer Service Advisor will confirm the details and give you a unique CMS reference number. On receipt of written confirmation of disposal quoting the CMS reference number credit will be raised on your behalf.
  • We are working with the supplier to provide a timeframe as to when FSB658 will be available to order and will update this ICN once more information in known.

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

Downloads ▼

  • 1875 3M Ranger Field Saftey Notice Letter November 2022

    An PDF file showing a Field Safety Notice letter for ICN 1875.
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