Product Recall – Kruuse 10ML Normject Syringes Pk100

9th August 2023

Kruuse  is recalling listed batches of their 10ml Norm-Ject disposable syringe – Pk100 which are detailed in the table below. This recall is a voluntary recall initiated by Kruuse. In the course of Post Market Surveillance activities internal quality checks have identified that in a subset of the above-mentioned article batch combinations the sterile barrier might be damaged. Whilst no injuries to patients, users or third parties have been reported to date, the deviation might harbour the risk of local, regional, and systematic infections up to patients’ death..

 

NVS Code Product Description Batch Number
183210 10ml Norm-Ject (HSW HENKE-JECT®)
disposable syringe  Pk100
22M28C8
23A09C8

 

 

What to do next – Please examine your stock immediately and take the following steps.

I have the affected product

  • Quarantine the product.
  • If you have any of the affected stock, then please contact our Customer Services Team on 01782 771111 (Option 3) to arrange the return of the products.
  • This affected product will only be accepted until 31st August 2023, after this date we will not accept this product.

I do not have this product

  • Unless you’ve received email notification that our records indicate you may have this product, no further action is required.

If you require any further information, please contact our Customer Service Department on 01782 771 111.

Kind regards,

Andrew Duxbury

(Responsible Person)