Supply Issues RB Medical Cervical OS Finder and Amniotic Hook Products FCC85111 and FCC85112 (ICN 2319)

• NHS Supply Chain recently suspended Five MedGyn products due to manufacturer medical certification issues. This is improving.
• Two Eurosurgical Ltd products FCB86331 – Postpartum Haemorrhage System Balloon Kit and FFY331 – Amniotic Hook are now available to order.
• Three product codes in total remain suspended and unavailable to order:
  • FCC85111 – Cervical OS finder
  • FCC85112 – Amniotic Hook
  • FPF278 – Word catheter.
• Customer products held in Trust stock, are not subject to any recall and we have not been notified of any patient safety incidents from the use of these products.
• NHS Supply Chain has decided to temporarily suspend these products until satisfied and when certification issues have been resolved.
• Potential indirect alternative products are available to order through our online catalogue.
• Unfortunately, there are still no alternatives available for FPF278 however, the products are still available to order directly from suppliers, in the interim.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives.
• We are currently working with the Medicines and Healthcare products Regulatory Agency to ensure products are available again to supply.
• If you have any further questions, please contact your local NHS Supply Chain Customer Services Advisor.
• We do not currently have a resolution date, we will update this ICN as soon as we have further information.

• NHS Supply Chain recently suspended eight MedGyn products due to manufacturer medical certification issues and this has now improved.
• Three Assistive Cessations products are now available to order:
  • FGR953, FGR968 and FPF279.
• Five product codes are suspended and unavailable to order:
  • FCC85111 – Cervical OS finder
  • FCC85112 – Amniotic Hook
  • FFY331 – Amniotic Hook
  • FPF278 – Word catheter
  • FCB86331 – Postpartum Haemorrhage System.
• Five product codes remain affected in total.
• Customer products held in Trust stock, are not subject to any recall and we have not been notified of any patient safety incidents from the use of these products.
• NHS Supply Chain decided to temporarily suspend these products until satisfied and when certification issues have been resolved.
• Potential indirect alternative products are available to order through our online catalogue.
• Unfortunately, there are no alternatives available for FPF278 however, the products are still available to order directly from suppliers, in the interim.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives.
• We continue to work with the Medicines and Healthcare products Regulatory Agency to ensure products are available again to supply.
• If you have any further questions, please contact your local NHS Supply Chain Customer Services Advisor.

Change:

• NHS Supply Chain is currently suspending listed MedGyn products due to manufacturer medical certification issues.
• Eight product codes are affected:
  • FCB86331 – Postpartum Haemorrhage System
  • FCC85111 – Cervical OS finder
  • FCC85112 – Amniotic Hook
  • FFY331 – Amniotic Hook
  • FGR953 – Assistive cessation
  • FGR968 – Assistive cessation
  • FPF278 – Word catheter
  • FPF279 – Assistive cessation.
• Customer products held in Trust stock, are not subject to any recall and we have not been notified of any patient safety incidents from the use of these products.

Impact:

• NHS Supply Chain has decided to temporarily suspend these products until satisfied and when certification issues have been resolved.
• Potential indirect alternative products are available to order through our online catalogue.
• Unfortunately, there are no alternatives available for FPF278 and FPF279 however, the products are still available to order directly from suppliers, in the interim.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives.
• The NHS Supply chain has not been alerted to the taxonomy or functional issues with the product however, until the certification anomalies have been corrected, as a responsible supplier of clinical products to the NHS we have decided to suspend sales and distribution of these products through our route until we have clarification and assurance that the certification is correct, and the product classification is accurate.
• We are currently working with the Medicines and Healthcare products Regulatory Agency to ensure products are available again to supply.

Next Steps:               

• Customers are advised to log into our website to view the potential indirect alternative products.
• Since these products are not the subject of a recall, Trusts have been informed of the current regulatory issue and the alternative products available, for a balanced decision to be taken locally whether to continue or discontinue use of these products.
• We will update the ICN within three weeks when we have further information.
• If you have any further questions, please contact your local NHS Supply Chain Customer Services Advisor.

Please note that due to the clinical nature of these alternative products, we advise you to consult your own clinical experts to ensure suitability for your organisations use of these products.