Henleys Medical Supplies Limited Umbilical Cord Clamp

Important Customer Notice Field Safety Notice

Ref: 2020/965 ICN Number: 965

Ref: MHRA 2020/002/005/401/014
Recall Ref: 84

Alert:

  • Henleys Medical Supplies Limited has issued a Field Safety Notice for 150101 Umbilical Cord Clamp on behalf of the manufacturer Plasti-med due to risk of malfunction during use.

Products Affected:

  • There are two batch numbers affected: 0070318 and 0120318.
  • This product is available from NHS Supply Chain as:
    NPC MPC Product Name Batch Number
    FFK148 150101 Umbilical Cord Clamp With locking device individually wrapped sterile 0070318 , 0120318
  • Please note no other batch numbers are affected.

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
  • If an affected product is identified, please contact your Customer Service Advisor who can arrange a return for full credit (reason code 7). All products are to be returned no later than 6 March 2020.

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

Change:

  • NHS Supply Chain has received reports of high-risk safety concerns regarding the Umbilical Cord Clamp supplied by Henley’s Medical Supplies Limited.
  • The affected product code is:
    FFK148 – Umbilical Cord Clamp With locking device individually wrapped sterile.
  • We have taken the approach to temporarily suspend the affected product whilst the issue and the root cause are being investigated.

Impact:

  • FFK148 is currently unavailable to order.
  • Potential indirect alternative product is available to order through our online catalogue.
  • See our Downloads ▼ section to view the product listing for further information on the affected product code and the potential alternatives.

Next Steps:

  • Customers are advised not to use FFK148 whilst this issue is being investigated.
  • Customers are advised to log into our website to view the potential indirect alternative product.
  • 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.

Downloads ▼

  • 965 Henleys Medical Product Listing with Alternatives

    An excel file detailing the affected product codes for ICN 965.

    Please to view this content.

  • 965 Henleys Medical Field Safety Notice

    A PDF document detailing the field safety notice for ICN 965.