Becton Dickinson Bard Safestep Huber Needle Sets

Important Customer Notice Field Safety Notice

Ref: 2020/1093 ICN Number: 1093

MHRA 2020/006/025/487/003
Recall Ref: 31

Alert:

  • Through customer feedback, Becton Dickinson has discovered that the specific lots of BARD SafeStep™ Huber Needle Sets listed in Attachment 1 have the potential to develop cracks or breaks in the tubing near the Luer or Y site of the device.
  • If a crack or break develops there are potential health risks to the User including exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood) through leakage. A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.

Products Affected:

  • Please See our Downloads ▼ section to view the product listing for full details of these products which are all available via NHS Supply Chain’s eDirect route.
  • Please note only the batch numbers quoted in the Field Safety Notice are affected.

Next Steps:

  • Inspect your inventory, locate and quarantine any units of the impacted devices listed in Attachment 1.
  • If you have further distributed the product, please identify those facilities, notify them at once of this product removal and have them destroy any unused units of the affected product.
  • Destroy any unused units of the affected product.
  • Complete the customer response form on page 3, together with Attachment 1 on page 4, as applicable, indicating:
    the quantities destroyed OR
    that your organisation does not have any impacted units left in inventory.
  • Becton Dickinson confirm this field safety notice has already been shared with their customers, and that where required will exchange affected products direct with users.
  • If you have not yet done so please return the Customer Reply form urgently to BDUKFieldAction@bd.com.

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

Downloads ▼

  • 1093 Becton Dickinson Field Safety Notice

    A PDF document of the Field Safety Notice for ICN 1093.
  • 1093 Becton Dickinson Product Listing

    An Excel file detailing the affected product codes for ICN 1093.

    Please to view this content.