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.