Urgent Field Safety Corrective Action – Polyfilm 12x14cm

16th August 2023

Urgent Field Safety Corrective Action – Polyfilm 12x14cm

FSCA – Identifier: 2308/48541/00
Type of Action: RECALL

Product Code:	Batch/Lot:	NHSSC Code:
VPEPF121401	A210007	FSQ3809
	A210008
	A220009

 

Description of Problem

This recall has been initiated by the Legal Manufacturer, PEROUSE MEDICAL.

PEROUSE MEDICAL became aware of a sealing problem on the packaging of some units of product code: VPEPF121401. If the packaging of POLYFILM has defective sealing, it can potentially lead to a loss of sterility of the device.

As a preventive measure, PEROUSE MEDICAL has decided to recall all batch numbers currently on the market.

Vygon (UK) Ltd can advise that the batch numbers listed in the table above are affected in the UK

Field Safety Corrective Action Instructions:

Advice on action to be taken by Medical Staff

1. Identify and quarantine any remaining stock of the affected product codes and batch/lot numbers.
2. If you do not have stock from the affected batch number, stated above, mark the according checkbox on the enclosed FSCA Fax Back Form, complete the form and send it to the following fax number: 01793 748899 or email: technical@vygon.co.uk.
3. If you have stock from the affected batch number, stated above, mark the according checkbox on the enclosed FSCA Fax Back Form, provide the additional information requested and send the completed form to the following fax number: 01793 748899 or email: technical@vygon.co.uk.
4. On receipt of the completed FSCA Fax Back Form, a Vygon (UK) Ltd. representative will contact you to arrange return of the affected stock and credit.
5. Please complete these actions by 20-09-2023.