Field Safety Notice BD Plastipak™ 50mL Syringe with Luer-Lok™ Tip FWC408 (ICN 1606)

Important Customer Notice Field Safety Notice

Ref: 2022/1606 ICN Number: 1606

MHRA:  2022/003/024/291/004

AlertFor The Immediate Attention Of Clinical Staff

  • BD has issued a Field Safety Notice to advise customers of a potential for air ingress into the BD Plastipak™ 50mL syringe when the syringe barrel is damaged, and the syringe is used in an infusion pump.
  • A damaged syringe barrel could result in a loss of contact between the stopper and the barrel wall, thereby creating a leak path.
  • It is believed that this air ingress, if injected into the patient, could result in a gas embolism.

Products Affected:

  • The affected product is available from NHS Supply Chain as:
NPC Product Description Supplier Code/ MPC Affected Lot
FWC408 BD Plastipak™ 50mL syringe 300865 All Lot Numbers Within Expiry

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products. See our Downloads ▼ section.
  • Follow Good Clinical Practice and apply additional vigilance regarding the inspection of medical devices for damage, integrity and function before, during, and after use. Devices found with damage should not be used.
  • There is no requirement for customers to return any product. These products can continue to be used in accordance with the guidance in the Field Safety Notice and observe Good Clinical Practice to inspect the product prior to use.
  • If you identify syringe damage, report as a complaint to your NHS Supply Chain Customer Service Advisor.
  • Return the completed customer response form found on page 4 of the Field Safety Notice to Plastipakfsa@sedgwick.com as soon as possible.

If you have any further questions, please contact your local NHS Supply Chain Customer Relationship Manager or Customer Services Advisor.

Downloads ▼

  • 1606 BD Field Safety Notice

    A PDF of the Field Safety Notice for ICN 1606.