Field Safety Notice Altomed Kirwan Surgical Products 25-Gauge Disposable Bipolar Pencils FSP11614 (ICN 2752)
Important Customer Notice Field Safety Notice
Alert:
- Altomed has notified NHS Supply Chain about a product recall issued by the manufacturer Kirwan Surgical Products LLC regarding their 25-Gauge Disposable Bipolar Pencils.
- Kirwan has issued this recall due to the recent increase in occurrence and potential severity evidenced by trend analysis is cause for concern.
- The manufacture has received complaints where the protective sheath detached during use, leading to injury.
Products Affected:
- One of the affected products has been supplied on NHS Supply Chain’s eDirect route after the 1 December 2022:
NPC |
Product Description | Supplier Code / MPC | Expiration Date |
Affected Lot Numbers |
FSP11614 |
Disposable Bipolar Pencil 25GA Straight |
Altomed: A5063
Kirwan: 14-5011 |
1 September 2027 or later |
220906 to 241002 |
- Please note only the Lot number range quoted above is affected.
- Future orders will be fulfilled with different, unaffected Lot numbers.
Next Steps:
- Cease use and quarantine the affected lot numbers.
- Contact the supplier by email at: Daniel.lant@altomed.com with full details of the products, including Lot numbers and quantities, in your possession.
- Affected products need to be collected from your Main Stores. Please include the postal address of your Main Stores in your response to allow the supplier to arrange the return.
- Once the affected products have been collected, please contact your local NHS Supply Chain Customer Service Advisor with these details to allow us to raise the appropriate credit on your behalf.
If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care team.
Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.