Important customer notice Recall

Product Recall DUET TRS

• Date:25/08/2011
• Product area:IV Therapy | Orthopaedics | Respiratory Care | Theatres |

NHS Supply Chain recall ref: 27
Ref: 2011/304
24 August 2011

URGENT – Product Recall
FGS426 FGS428 FGS429 FGS431 FGS432
Duet TRS™ Universal straight and Articulating Single use loading units (SULU)

NHS Supply Chain has received notification of an Urgent Field Safety Notice issued by Covidien.

Description of Problem

Covidien has made the decision to voluntarily withdraw affected lots of Duet TRS™
Universal straight and Articulating single use loading units (SULU).

Covidien is conducting the voluntary recall due to the potential for the sterility and moisture barrier to be compromised.
The use of products in this condition may result in a potentially increased risk for infection and/or degradation of the reinforced material.
Covidien have identified NHS Supply Chain Customers and will contact them direct to arrange replacement products.

For affected products please see attachment below.

For further information on the recall, please contact your local NHS Supply Chain Customer Service advisor.

Action Required

Covidien is conducting a voluntary Field Safety Corrective Action for a limited number of Duet TRS™.  This voluntary Action is being conducted with the knowledge of the relevant Regulatory Agencies.

1. Inspect your inventory and segregate any unused product
2. Please complete the attached verification form in its entirety. Fax the completed form to 01329 224418, (available in the attachment below)
3. Covidien customer service will contact customers directly who have purchased any of the affected lots and arrange collection and exchange of the products.

This notice needs to be passed on all those who need to be aware within your organisation or to any organisation where the potentially affected devices have been transferred.

This voluntary recall is limited to the lots and code numbers identified in the Covidien letter attached below and does not affect any other lots of Covidien devices.

Please see attachment below which provides full details of affected lot numbers and instruction to follow, we strongly recommend you follow the advice outlined in the attachment.

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