Patient Safety Alert Lisclare MySling Design Change Multiple Products (ICN 1798)

Important Customer Notice Update

Ref: 2022/1798 ICN Number: 1798
  • Lisclare has confirmed the original specification of the MySling range is back in stock and they are now available to fulfil new orders.
  • All the new design slings have been quarantined and will not be shipped for any new orders placed.
  • The 10 product codes previously affected are now available to order from NHS Supply Chain.
  • Please note if you received slings from the impacted batches, You must ensure the corrective action has been taken as per the options detailed in the update provided on 30 August 2022.

Update:

  • Lisclare have provided two Field Safety Notices FSN1001 and FSN1002 dated 25 August 2022.
  • The Field Safety Notices confirm the details of the modifications made to improve patient comfort but also affecting the sizing.
  • Lisclare advise the sling remains safe to use if correctly sized but understand that some patients may have been assessed using the original design sling. In this case it is important that they are properly reassessed by a suitably qualified individual before being issued with a new sling.
  • Please see our Downloads section to refer to the Field Safety Notices for full details of the affected lot numbers.
  • Affected MySling Clip slings were shipped on or after 1 June 2022.
  • Affected MySling Loop slings were shipped on or after 1 July 2022.

Corrective Action:

  • Option one
    • All patients are reassessed by a suitably qualified individual before being lifted using one of the affected products.
  • Option two
    • Remove all affected products from use and contact Lisclare to arrange collection. Email: quality@lisclare.com or telephone: 0151 495 5750.
    • Any unused product will be replaced with new units in the original design, free of charge or refunded in full.
  • If you choose option two for exchange or refund, please also contact your local NHS Supply Chain Customer Service Advisor with full details including whether you will accept exchange or require credit.
  • Whichever option you choose please complete the Customer Response Form, page 5 Appendix 1 and return to: quality@lisclare.com.

MHRA TBC
NHSSC : 42

Alert:

  • We have identified a change in the design of the MySling slings which are awarded on the Pressure Area Care and Patient Handling framework.
  • The full extent of these sling modifications across the product range is not yet established.
  • Initial reports received suggest that the modified slings differ in size and the measuring information provided with the product does not reflect the new design.
  • The changes in design, size alteration and incorrect information for use pertinent to this modified product carries a potential risk of harm to the patient, and healthcare professionals.
  • Currently, of the 96 products listed with NHS Supply Chain in the MySling range, we are aware of 10 products that have been associated with these changes which carry safety risk.
  • There have been modifications made to the design of these slings which can cause patient safety risk.

Products Affected:

  • There are currently 10 affected products available from NHS Supply Chain.
  • The affected products are currently unavailable to order.
  • See our Downloads section to access the product listing for further information on the affected product codes.
  • Lisclare are going to reinstate the old version of the affected slings within the next few weeks.
  • For the products affected, the lot/batch numbers are not yet known, however, we are in the process of confirming this with the supplier.

Next Steps:

  • Please review all existing stock to identify products affected by these changes. If an organisational decision is to use affected product, then an organisational risk assessment is to be carried out prior to product utilisation.
  • NHS Supply chain will update as more information becomes available.
  • Please refer to the product listing and online catalogue for information on indirect alternatives.
  • If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or Customer Relationship Manager.

Downloads ▼

  • 1798 Lisclare Product Listing with Alternatives 24 August 2022

    An Excel file showing the product listing with alternatives for ICN 1798.
    Login to view the downloads
  • 1798 Lisclare MySling HighBack Clip Slings Field Safety Notice FSN1001 30 August 2022

    A PDF file showing the Clip Slings Field Safety Notice for ICN 1798.
  • 1798 Lisclare MySling HighBack Loop Slings Field Safety Notice FSN1002 30 August 2022

    A PDF file showing the Loop Slings Field Safety Notice for ICN 1798.