Field Safety Notice LeMaitre TufTex®  Over the Wire Embolectomy Catheter and Pruitt®  Occlusion and Irrigation Occlusion Catheter (ICN 2942)

NHSSC: 19

Alert:

• LeMaitre has issued a Field Safety Notice following discovery of inadequate tray seals during testing.
• There is a risk of infection to the patient if the sterile barrier of the packaged device is broken.
• LeMaitre advise only patients undergoing surgery with the use of the TufTex® Over-the-Wire Embolectomy Catheters, Pruitt® Occlusion Catheters, or Pruitt® Irrigation Occlusion Catheters are at risk.
• LeMaitre advise they have not received any complaints about this issue. Following inspection and testing of finished product samples, the results suggest that only approximately 1% of the population may have a compromised package.

Products Affected:

• There are 13 products affected available on the eDirect service from NHS Supply Chain.
• Please refer to the product listing for full details.
• Please note only the lot numbers quoted in the ‘Impacted Lots List’ are affected.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine all the affected lot numbers.
• Complete the Customer Reply Form, page 6 of the Field Safety Notice, and return to: recall-UK@lemaitre.com.
• On receipt of the completed form LeMaitre will contact you to arrange collection, and replacement of the affected stock in your possession.
• Please also contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products in your possession, including product codes, lot numbers and quantity. Your Customer Services Advisor will give you a unique CMS log number, which should be quoted to us if you require our help with this transaction.

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.