Becton Dickinson Illinois Bone Marrow Aspiration/Intraosseous Needle (ICN 1351)

Important Customer Notice Field Safety Notice

Ref: 2021/1351 ICN Number: 1351

MHRA TBA
Recall Ref: 41

Alert:

  • Becton Dickinson has issued a Field Safety Notice withdrawing all lot numbers of the Illinois Bone Marrow Aspiration/ Intraosseous Needle following discovery of the potential for the needle protector to become dislodged within the packaging which could allow the needle of the device to puncture the packaging, compromising the sterile barrier.
  • This defect could result in health consequences including a varying degree of infection. Management of the patient, including but not limited to, administration of antimicrobial therapy and any patient follow-up, is at the discretion of the treating physician.
  • In addition, this defect could result in a potential needlestick injury for the caregiver if an exposed needle is not identified.

Products Affected:

  • This product is available from NHS Supply Chain’s eDirect route as:
NPC Product Description Supplier Code/MPC Affected Lots
FYU2753 Illinois Biopsy Needle 15g / 3” TIN2015 ALL

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
  • Whether the affected products are found or not, complete the Customer Response Form, page four of the Field Safety Notice and email to quality@ukmedical.com. Please note this is the distributor on behalf of BD, who require this confirmation by 10 September 2021 or as soon as possible after.
  • Where affected products are identified you should also contact your NHS Supply Chain Customer Service Advisor with full details. You will be asked to dispose of the impacted products in accordance with your local regulations. On written confirmation, NHS Supply Chain will raise credit on your behalf.
  • BD has identified the root cause and is taking corrective actions to prevent recurrence of this issue.
  • BD are currently manufacturing new stock which will be shipped to UK Medical with the dates to be confirmed. All outstanding orders will be held and supplied as soon as fresh product is available. Please contact your local NHS Supply Chain Customer Service Advisor if you do not wish to have these sent on.
  • NHS Supply Chain offers a range of Biopsy needles via the Interventional Radiology Portfolio, available to view on our online catalogue. Due to the clinical nature of these devices, customers would need to have their clinicians review to ascertain if these were suitable alternatives for their intended purpose.
  • This ICN will be updated with further information as it becomes available.

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

Downloads ▼

  • 1351 Becton Dickinson Field Safety Notice

    A PDF file detailing Field Safety Notice information and instructions for ICN 1351.