Product Update 3M™ Ranger™ Blood and Fluid Warming High Flow Sets FSB658 and FFF430 (ICN 1875)
Important Customer Notice Update
Ref: 2022/1875 ICN Number: 1875
- The supplier 3M™ Ranger™ has informed us that product code FSB658 has now passed all verification and validation processes at both supplier and manufacturing sites.
- The next step in the process requires sterilisation which takes approximately two months, therefore the finished product is on hold until sterilisation validation checks are completed and change management implementation phase has been approved.
- The raw material constraints are a dynamic situation therefore there is no substantial supplier concerns from a 3M perspective.
- Target completion for fulfilling orders against FSB658 is 1 April 2023.
- The supplier 3M™ Ranger™ has informed us that the issues relating to specific Lots of Blood and Fluid Warming High Flow Sets are ongoing.
- Two product codes remain affected:
- FSB658 – Blood and fluid warming High flow disposable set for Ranger blood and fluid warmer is currently suspended and is unavailable to order
- FFF430 – Blood and fluid warming High flow disposable set for Ranger blood and fluid warmer was delisted from our catalogue in 2022 and is no longer available to order.
- The product issue is now anticipated to be resolved by 30 April 2023.
- 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.
- 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.
- 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.