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Urgent Field Safety Corrective Action 

Posted by Vygon (UK) Ltd  on 17-September-2014 
Urgent Field Safety Corrective Action

16th September, Urgent Field Safety Corrective Action.    MULTICATH EXPERT 5LUMEN 9.5FG/16CMS

FSCA – Identifier: 1409/32597/12

Type of Action: RECALL DEVICE

Details of Affected Devices:

Product Code: 8159.167 Lot/Batch Number: 020414GE

 

 

 

 

 

Description of Problem

Approximately 148 x incorrect catheters (Size: 8.5fr, 12.5cm, 4 x lumens) have been supplied within product code: 8159.167, batch number: 020414GE. This manufacturing related error may result in the following risks: 

  • Incorrect Positioning – due to the decreased length of the incorrectly supplied catheters, the catheter tip may not reach the desired position/location during placement.
  • Insufficient Lumens – the incorrect catheters incorporate four lumens. Therefore, an additional catheter or extension set may be required following placement to establish five routes of access.

 

Field Safety Corrective Action Instructions: Advice on action to be taken by Medical Staff

1. Identify and quarantine any remaining stock of 8159.167, 020414GE

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 replacement products from an alternative batch number.

5. Please complete actions by 31st October 2014. 

 

Instruction for Distributors of affected batch numbers

If you are a distributor, please provide this Field Safety Corrective Action (FSCA) to all your customers who have received products of the affected batch number, as stated above. Please send your customers the following documents:

  • A copy of this Field Safety Corrective Action
  • A copy of the FSCA Fax Back Form 

 

The FSCA Fax Back Form should be completed by your customer and returned to you.

As a distributor you are required to confirm to Vygon (UK) Ltd that you have completed the instructed activity for all of your customers affected by this Field Safety Corrective Action. Please forward all completed FSCA Fax Back Forms to the following fax number: 01793 748899 or email: technical@vygon.co.uk

Please also identify and quarantine any remaining stock of the affected batch number in your warehouse, complete the FSCA Fax Back Form and forward it to the following fax number: 01793 748899 or email: technical@vygon.co.uk.

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 replacement products from an alternative batch number.

Vygon (UK) Ltd

Vygon (UK) Ltd has informed all customers, employees of Vygon (UK) Ltd and distributors of this Field Safety Corrective Action.

Transmission of this Field Safety Corrective Action

This notice needs to be passed on to all recipients/users of this product within your organisation, in particular, the following:

  • All Wards
  • Risk Managers
  • Health and Safety Managers
  • Purchasing Managers
  • Medical Directors
  • Nursing Directors
  • ITU Directors
  • A&E Directors
  • Stores
  • Cardiac Units
  • Theatres
  • ITU/HDU Units
  • Maternity Units
  • Critical Care Units
  • Radiology

 

Please consider all end users, clinicians, risk managers, supply chain/distribution centres etc. in the circulation of this FSCA.

Please maintain awareness of this FSCA and resulting action for an appropriate period to ensure effectiveness of the corrective action.

 

Contact Person

Kate O’Connell

Technical Support Department

Vygon (UK) Ltd

The Pierre Simonet Building

V Park, Gateway North

Latham Road

Swindon

Wiltshire SN25 4DL

Telephone: 01793 748800

Vygon (UK) Ltd apologise for any inconvenience this FSCA may cause. Vygon (UK) Ltd can confirm that this FSCA has been communicated to the MHRA.  

For more information please use the Contact Form