PAJUNK Sprotte NRFit Spinal Needle (ICN 1420)

Important Customer Notice Field Safety Notice

Ref: 2021/1420 ICN Number: 1420

MHRA TBA

Recall NHSSC Ref: 54

Alert:         

  • PAJUNK® GmbH Medizintechnologie received information from the field about a problem which has occurred in the packaging during the manufacturing of certain products.
  • Due to this problem, PAJUNK® GmbH Medizintechnologie cannot guarantee with sufficient certainty that the needle´s specification identified in the label which is SPROTTE® NRFit® matches with the content.
  • In the case of failure to comply with this customer information there is a risk of using a puncture needle which afterwards cannot be used with an infusion device e. g. a syringe with an NRFit connector because the connection does not match. The procedure may be delayed or require re-puncture with a NRFit® needle (if available).

Products Affected:

  • Products affected are available from NHS Supply Chain as:
NPC Product Description Supplier Code/ MPC Supply Route
FTR2304 Sprotte NRFit Spinal Needle with Introducer 25g x 120mm 051163-29A Stocked
  • The affected batch numbers are 1338,1343.
  • Current stock holding in NHS Supply Chain warehousing has been checked and is all of different, unaffected batch numbers.

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
  • Complete and return the Reply Form, attachment 2, to safety@pajunk.com.
  • In addition, where unused devices are found of the affected lot numbers please contact your local NHS Supply Chain Customer Services Advisor with full details to arrange a return for full credit (reason code 7 Supplier Recall). Please confirm if the quantity of product to be returned is the unit of issue, pack 10, or single unopened devices.
  • All products to be returned no later than Friday 19 November 2021.
  • If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.

Downloads ▼

  • 1420 PAJUNK Field Safety Notice

    A PDF of the Field Safety Notice for ICN 1420.