Supply Issues Laborie Medical T-doc Catheters Multiple Products (ICN 1788)

• The supplier Laborie Medical has informed us that the supply issue with its T-doc Catheters is still ongoing.
• The anticipated resolution date is now 10 March 2023.

Change:

• The supplier Laborie Medical has informed us of a product update to its T-doc Catheters.
• Three products codes are now available:
  • FSS1076 – Urodynamic system Pump tubing set
  • FUQ116 – Urodynamic Accessory Dipoable cytocopic injection needle short
  • FUQ117 – Urodynamic Accessory Dipoable cytocopic injection needle long.
• There are 10 product codes available while stocks last and may become suspended.
• The delay is due to the MDR certification process for T-doc catheters. The suppliers has been informed the certification process will not be completed before their current CE certification expires on 2 August 2022.

Impact:

• The supplier is continuing to work with the Notified Bodies to expedite the issuing of the renewed certificates.
• The estimated completion date for MDR certification process is now October 31, 2022.
• There are currently no identified alternatives for the affected products.
• Customers are advised to continue to place orders as normal for the affected products but please be aware that orders may not be supplied in full until the certification is complete.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes.
• The supply issues are anticipated to be resolved by 31 January 2023.

• A further nine product codes are now affected by the supply issue.
• Three product codes have now been delisted as a result of the supply issue:
  • FSS10076 – Pump infusion set urodynamic Mms libra libra plus solar
  • FUQ082 – Catheter urodynamic Bladder filling 6f 400m
  • FUQ083 – Catheter urodynamic 2lumen for upp 6 fr 400mm pves 6mm from tip pura 66mm from tip.
• There are now 13 product codes currently available while stocks last.
• See our Downloads section to access the product listing for further information on the affected product codes.
• There are currently no identified alternatives for the affected products.
• Customers are advised to continue to place orders as normal for the affected products but please be aware that orders may not be supplied in full until the certification is complete.
• The supply issue is now anticipated to be resolved by 30 November 2022.

Change:

• The supplier Laborie Medical Technologies UK Ltd has informed us of a potential supply issue with some of its T-doc Catheters.
• The four product codes affected are:
  • FSS1087 – Catheter urodynamic 7FA TDOC Abdominal 7 FR
  • FSS1088 – Catheter urodynamic 7FS single TDOC 7 FR
  • FUQ085 – Catheter urodynamic Tdoc 7fd dual sensor
  • FSS1076 – Urodynamic system Pump tubing set.
• The supply issue is due to the potential expiration of its current CE certification before the re-certification under MDR is completed.

Impact:

• The affected codes are currently available while stocks last.
• See our Downloads section to access the product listing for further information on the affected product codes.
• The supply issue is anticipated to be resolved by 31 October 2022.

Next Steps:

• Customers are advised to continue to place orders as normal for the affected products but please be aware that orders may not be supplied in full until the certification is complete.
• If you have any further questions, please contact your local NHS Supply Chain Customer Relationship Manager or Customer Services Advisor.