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Field Safety Notice Delta Surgical Haemostats Multiple Products (ICN 1770)

Important Customer Notice Update

Ref: 2022/1770 ICN Number: 1770

Update:

  • Delta Surgical Ltd, UK distributor for the Gelita range of Haemostats, has been notified of the attached preventative recall on GELITA TUFT-IT® products sold over the last five years.
  • In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.

Products Affected:

  • One additional NHS Supply Chain product is affected, FKV10889.
  • Please refer to the product listing, Field Safety Notice and Annex One document for further product information.
  • All lots within expiry are affected.
  • Please note this product is delisted and unavailable to order.

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
  • Cease use of the affected product, quarantine and contact your NHS Supply Chain Customer Service Advisor with full details including, confirmation of the lot number and full quantity in eaches.
  • Your Customer Service Advisor will confirm the details and on written confirmation of safe disposal arrange full credit on your behalf.

MHRA Reference: TBC
NHS Supply Chain Reference: 37

Alert:

  • Delta Surgical Ltd, UK distributor for the Gelita range of Haemostats, has been notified of the attached preventative recall on GelitaSpon (R) products sold over the last five years.
  • In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
  • Since these ‘outliers’ in testing cannot be reconciled at this time, GELITA MEDICAL GmbH, has decided to take a very conservative approach and recall all products, even those found to be within specification.

Products Affected:

  • There are 15 NHS Supply Chain products affected.
  • Please refer to the product listing, Field Safety Notice and Annex 1 document for further product information.
  • All lots within expiry are affected.
  • 12 affected products are now delisted and unavailable to order.
  • Three products have been suspended until unaffected product can be supplied. This is estimated to be towards the end of the year.
  • Customers are advised to log into our website to view the potential indirect alternative products.

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
  • Cease use of the affected product, quarantine and contact your NHS Supply Chain Customer Service Advisor with full details including, confirmation of the lot number and full quantity in eaches.
  • Your Customer Service Advisor will confirm the details and on written confirmation of safe disposal arrange full credit on your behalf.

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

Downloads ▼

  • 1770 Field Safety Notice 21 September 2022

    A PDF detailing the full Field Safety Notice for ICN 1770.
  • 1770 Delta Surgical Field Safety Notice Letter 21 September 2022

    A letter to support this Field Safety Notice from the supplier.
  • 1770 Delta Surgical Field Safety Notice Annex One 21 September 2022

    A file to support the information published with this ICN.
  • 1770 Delta Surgical Field Safety Notice Affected Batches 21 September 2022

    A PDF detailing the affected batches for ICN 1770.
  • 1770 Delta Surgical Product Listing with Alternatives 21 September 2022

    An Excel file detailing the affected product codes for ICN 1770.
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